FDA Product Code
FDA Product Code DSI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1025
510(k) Clearances — 398 records · page 3 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K913576 | DATASCOPE MODEL VISA CENTRAL MONITOR | Accucore, Inc. | 1992-01-28 | Traditional | PDF ↗ |
| K913339 | HORIZON PACEMAKER DETECTION SOFTWARE | Mennen Medical, Inc. | 1992-01-08 | Traditional | PDF ↗ |
| K912744 | ORG-8200A UNIVERSAL SIGNAL HOUSING | Nihon Kohden America, Inc. | 1991-12-09 | Traditional | PDF ↗ |
| K903940 | TYPE 9210 S/ECG | S & W Medico Teknik | 1991-12-04 | Traditional | PDF ↗ |
| K913451 | HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS | Hewlett-Packard Co. | 1991-10-31 | Traditional | PDF ↗ |
| K910109 | CARDIOSWISS CM-8 | Care Systems, Inc. | 1991-09-23 | Traditional | PDF ↗ |
| K905506 | ACCUCORE TELEMETRY, MODIFICATION | S & W Medico Teknik | 1991-09-06 | Traditional | PDF ↗ |
| K910808 | Q-SMART HOLTER SYSTEMS | Quinton, Inc. | 1991-07-17 | Traditional | PDF ↗ |
| K900385 | ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE | Parexel Intl. Corp. | 1991-07-09 | Traditional | PDF ↗ |
| K910490 | MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A | Hewlett-Packard Co. | 1991-04-26 | Traditional | PDF ↗ |
| K900366 | ARRHYTHMIA 9215 | S & W Medico Teknik | 1991-04-26 | Traditional | PDF ↗ |
| K910291 | MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION | Hewlett-Packard Co. | 1991-04-22 | Traditional | PDF ↗ |
| K903514 | FUKUDA DENSHI MODEL LX-3100 | Fukuda Denshi USA, Inc. | 1991-01-30 | Traditional | PDF ↗ |
| K900720 | MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED) | Mortara Instrument, Inc. | 1990-11-05 | Traditional | PDF ↗ |
| K900607 | MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11 | Cardiodata Corp. | 1990-10-16 | Traditional | PDF ↗ |
| K903704 | FUKUDA DENSHI MODEL FCP-2201 MODIFICATION | Fukuda Denshi USA, Inc. | 1990-09-07 | Traditional | PDF ↗ |
| K900540 | TRAM PATIENT MONITOR | Marquette Electronics, Inc. | 1990-07-17 | Traditional | PDF ↗ |
| K900246 | CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512 | Ppg Industries, Inc. | 1990-07-03 | Traditional | PDF ↗ |
| K900319 | SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM | Siemens Medical Electronics | 1990-06-28 | Traditional | PDF ↗ |
| K897074 | MODEL 215M PATIENT SIMULATOR | Dynatech/Nevada, Inc. | 1990-05-17 | Traditional | PDF ↗ |
| K896775 | PCI MODEL 2041-B TELEMETRY MONITOR | Accucore, Inc. | 1990-05-17 | Traditional | PDF ↗ |
| K896862 | MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM | Del Mar Avionics | 1990-04-18 | Traditional | PDF ↗ |
| K895806 | ELATEC HOLTER ANALYZER | Ela Medical, Inc. | 1990-04-04 | Traditional | PDF ↗ |
| K896967 | HTS 820 CARDIAC MONITOR | Life Sensing Instrument Company, Inc. | 1990-03-19 | Traditional | PDF ↗ |
| K895547 | GRANDCOR/CARDIOLINE ECT STRESS TESTING | Grandcor Medical Systems | 1990-03-13 | Traditional | PDF ↗ |
| K896771 | EKG, ECG KENZ, ECG 302 | Cambridge Medical Instruments, Inc. | 1990-02-26 | Traditional | PDF ↗ |
| K894543 | MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER | Del Mar Avionics | 1990-02-08 | Traditional | PDF ↗ |
| K897063 | FUKUDA DENSHI MODEL DS-3300 ETR | Fukuda Denshi USA, Inc. | 1990-02-01 | Traditional | PDF ↗ |
| K895266 | AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED | Biosensor Corp. | 1990-01-26 | Traditional | PDF ↗ |
| K896103 | MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR | Advanced Medical Products, Inc. | 1990-01-18 | Traditional | PDF ↗ |
| K894628 | MODEL DS-3300 DYNASCOPE PATIENT MONITOR | Fukuda Denshi USA, Inc. | 1990-01-08 | Traditional | PDF ↗ |
| K895208 | ZYMED MODEL 1610 | Agilent Technologies | 1989-12-12 | Traditional | PDF ↗ |
| K884643 | 1100 VITAL SIGNS MONITOR | Criticare Systems, Inc. | 1989-10-30 | Traditional | PDF ↗ |
| K894858 | CARE 5000 SYSTEM | Care Systems, Inc. | 1989-10-12 | Traditional | PDF ↗ |
| K894692 | BEDSIDE MONITORS, BSM-8301A, BSM-8302A | Nihon Kohden America, Inc. | 1989-10-02 | Traditional | PDF ↗ |
| K894460 | SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA | Siemens Medical Electronics | 1989-10-02 | Traditional | PDF ↗ |
| K894285 | DMI PC HOLTER SCANNER | Diagnostic Medical Instruments | 1989-09-26 | Traditional | PDF ↗ |
| K882818 | SEER | Marquette Electronics, Inc. | 1989-06-22 | Traditional | PDF ↗ |
| K890323 | MAX-1 (EXERCISE ELECTROCARDIOGRAPH) | Marquette Electronics, Inc. | 1989-06-16 | Traditional | PDF ↗ |
| K885256 | MEDILOG EXCEL ECG ANALYSIS SYSTEM | Oxford Medical, Inc. | 1989-05-31 | Traditional | PDF ↗ |
| K891148 | MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM | Del Mar Avionics | 1989-05-11 | Traditional | PDF ↗ |
| K890330 | MEDILOG 6000-FD REPORT GENERATOR | Oxford Medilog, Inc. | 1989-04-20 | Traditional | PDF ↗ |
| K885204 | HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS) | Mennen Medical, Inc. | 1989-04-19 | Traditional | PDF ↗ |
| K890338 | MEDILOG EDITOR | Oxford Medilog, Inc. | 1989-04-19 | Traditional | PDF ↗ |
| K884524 | HTS 220 CARDIAC MONITOR | Life Sensing Instrument Company, Inc. | 1989-04-10 | Traditional | PDF ↗ |
| K882206 | SUPERMON ARRHYTHMIA MODULE 7270 | Kontron Instruments, Inc. | 1989-04-05 | Traditional | PDF ↗ |
| K884216 | 506 NON-INVASIVE VITAL SIGNS MONITOR | Criticare Systems, Inc. | 1989-03-16 | Traditional | PDF ↗ |
| K884106 | SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL | Siemens Medical Solutions USA, Inc. | 1989-03-06 | Traditional | PDF ↗ |
| K884887 | MODEL 499 SSR ANALYSIS SYSTEM | Del Mar Avionics | 1989-02-06 | Traditional | PDF ↗ |
| K883440 | E550 ELECTROCARDIOGRAPH | Burdick Corp. | 1989-01-17 | Traditional | PDF ↗ |
| K884539 | HOLTER 24-HOUR ECG PLAYBACK, MODEL 150 | Rmv Medical (Romavat, Inc.) | 1989-01-17 | Traditional | PDF ↗ |
| K880505 | ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-301 | Ppg Industries, Inc. | 1988-12-27 | Traditional | PDF ↗ |
| K884152 | CENTURY COLOR TRACE | Biomedical Systems, Inc. | 1988-12-15 | Traditional | PDF ↗ |
| K882978 | Q4000 OPTION FOR Q4000 | Quinton, Inc. | 1988-11-01 | Traditional | PDF ↗ |
| K883410 | CARDIOMEGA-T | Grandcor Medical Systems | 1988-10-17 | Traditional | PDF ↗ |
| K883103 | EPICARDIA PC/FC | Medicomp, Inc. | 1988-09-22 | Traditional | PDF ↗ |
| K881488 | HOLTER SCANNER | Cardiodata Corp. | 1988-09-20 | Traditional | PDF ↗ |
| K881905 | MODEL MICRO SI AMBULATORY ECG MONITOR | Advanced Medical Products, Inc. | 1988-08-02 | Traditional | PDF ↗ |
| K881273 | HORIZON 2000 ARRHYTHMIA MONITORING OPTION | Mennen Medical, Inc. | 1988-07-12 | Traditional | PDF ↗ |
| K882513 | MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR | Cardiac Resucitator Corp. | 1988-07-12 | Traditional | PDF ↗ |
| K880664 | MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED) | Mortara Instrument, Inc. | 1988-03-09 | Traditional | PDF ↗ |
| K870816 | KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM | Kontron Instruments, Inc. | 1988-03-01 | Traditional | PDF ↗ |
| K871572 | RHYTHMSCAN | Brentwood Instruments, Inc. | 1988-02-22 | Traditional | PDF ↗ |
| K873533 | SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE | Medical Electronics Laboratories, Inc. | 1988-01-29 | Traditional | PDF ↗ |
| K873874 | CARDIOFAX-V ECG-8110A | Nihon Kohden America, Inc. | 1988-01-07 | Traditional | PDF ↗ |
| K874768 | FUKUDA DENSHI MODEL FCP-231 | Fukuda Denshi USA, Inc. | 1987-12-18 | Traditional | PDF ↗ |
| K873680 | MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM | Oxford Medilog, Inc. | 1987-11-23 | Traditional | PDF ↗ |
| K872837 | EPICARIDA, LE | Medicomp, Inc. | 1987-11-04 | Traditional | PDF ↗ |
| K862947 | THE EXPERT MODELS RTS 2000 AND RTS 2000H | Ocg Technology, Inc. | 1987-11-04 | Traditional | PDF ↗ |
| K871344 | PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR | Reynolds Medical , Ltd. | 1987-10-20 | Traditional | PDF ↗ |
| K872497 | MODEL MR-45 AMBULATORY HOLTER MONITOR | Oxford Medilog, Inc. | 1987-10-06 | Traditional | PDF ↗ |
| K872241 | LIFESCOPE 12, BSM 8500A PATIENT MONITOR | Nihon Kohden America, Inc. | 1987-09-30 | Traditional | PDF ↗ |
| K871389 | HOLTER ST SYSTEM, MODEL NO. 5000-20 | Holter Data Services | 1987-09-01 | Traditional | PDF ↗ |
| K871890 | CARDIO-MEGA SYSTEM | Grandcor Medical Systems | 1987-06-12 | Traditional | PDF ↗ |
| K871251 | CIRCAMED FULL DISCLOSURE SYSTEM | Circadian, Inc. | 1987-05-22 | Traditional | PDF ↗ |
| K871025 | FUKUDA DENSHI MODEL FCP-15 | Fukuda Denshi USA, Inc. | 1987-03-24 | Traditional | PDF ↗ |
| K865030 | CARDIOFAX-V ECG-8240A | Nihon Kohden America, Inc. | 1987-03-10 | Traditional | PDF ↗ |
| K865032 | CARDIOFAX-V ECG-834OA | Nihon Kohden America, Inc. | 1987-03-10 | Traditional | PDF ↗ |
| K864401 | PLURIMUS CARDIAC EVALUATION SYSTEM | Vivix Corp. | 1987-03-03 | Traditional | PDF ↗ |
| K864149 | Q-SCAN II AND Q-SCAN III | Quinton, Inc. | 1986-12-10 | Traditional | PDF ↗ |
| K863643 | EPICARDIA, PC/FD | Medicomp, Inc. | 1986-12-05 | Traditional | PDF ↗ |
| K864506 | SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1 | Spacelabs, Inc. | 1986-11-25 | Traditional | PDF ↗ |
| K864505 | SPACELABS ARRHYTHMIA NET (TM) LEVEL 2 | Spacelabs, Inc. | 1986-11-24 | Traditional | PDF ↗ |
| K862316 | CASE 12 | Marquette Electronics, Inc. | 1986-11-20 | Traditional | PDF ↗ |
| K863724 | MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM | Oxford Medilog, Inc. | 1986-11-20 | Traditional | PDF ↗ |
| K863159 | Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR | Quinton, Inc. | 1986-10-06 | Traditional | PDF ↗ |
| K862375 | CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM | Grandcor Medical Systems | 1986-07-01 | Traditional | PDF ↗ |
| K860980 | PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III | Spacelabs, Inc. | 1986-05-21 | Traditional | PDF ↗ |
| K852250 | 595 ARRHYTHMIA MONITORING SYSTEM | Burdick Corp. | 1986-05-02 | Traditional | PDF ↗ |
| K861240 | BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER | Mountain View Medical | 1986-05-02 | Traditional | PDF ↗ |
| K860950 | SCM-400 HOLTER SYSTEM | Fukuda Denshi USA, Inc. | 1986-05-02 | Traditional | PDF ↗ |
| K860470 | DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST | Del Mar Avionics | 1986-04-30 | Traditional | PDF ↗ |
| K860471 | DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER | Del Mar Avionics | 1986-04-30 | Traditional | PDF ↗ |
| K860834 | SPACELABS MEDICAL WORKSTATION | Spacelabs, Inc. | 1986-04-29 | Traditional | PDF ↗ |
| K860767 | MODEL E 600 ELECTROCARDIOGRAPH | Kone Instruments, Inc. | 1986-04-23 | Traditional | PDF ↗ |
| K860024 | FUKUDA DENSHI CARDIMAX FCP-211 | Brentwood Instruments, Inc. | 1986-03-31 | Traditional | PDF ↗ |
| K860167 | PRODIGY AND PRODIGY PLUS | Cardiodata Corp. | 1986-03-31 | Traditional | PDF ↗ |
| K853669 | MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL | Hewlett-Packard Co. | 1986-03-31 | Traditional | PDF ↗ |
| K860078 | MEDILOG 2500 SYSTEM | Oxford Medilog, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K860079 | MEDILOG 4500 SYSTEM | Oxford Medilog, Inc. | 1986-02-26 | Traditional | PDF ↗ |
Product code DSI · Class II · Cardiovascular. Data: openFDA.