FDA Product Code
FDA Product Code DRR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2050
510(k) Clearances — 24 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K022660 | BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 | Biocheck, Inc. | 2002-12-19 | Traditional | PDF ↗ |
| K971570 | EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 | Quinton Electrophysiology Corp. | 1997-12-29 | Traditional | PDF ↗ |
| K925346 | EP AMP, MODEL #901 | Quinton Electrophysiology Corp. | 1993-04-30 | Traditional | PDF ↗ |
| K914381 | HORIZON 9000/HIS OPTION AMPLIFIER | Mennen Medical, Inc. | 1992-01-28 | Traditional | PDF ↗ |
| K911935 | CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED | Gould, Inc. | 1991-07-22 | Traditional | PDF ↗ |
| K910307 | CARDIOLAB AMPLIFIER MODULE (CAM) | Prucka Engineering, Inc. | 1991-04-12 | Traditional | PDF ↗ |
| K894735 | ASC-952 PHYSIOLOGICAL AMPLIFIER | Astro-Med, Inc. | 1989-09-18 | Traditional | PDF ↗ |
| K894161 | ASC-950 ECG AMPLIFIER | Astro-Med, Inc. | 1989-08-03 | Traditional | PDF ↗ |
| K874441 | BARD BIOPOTENTIAL AMPLIFIER | C.R. Bard, Inc. | 1988-01-19 | Traditional | PDF ↗ |
| K853652 | BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT | Fisher Imaging Corp. | 1986-01-16 | Traditional | PDF ↗ |
| K813123 | EPC FILTER | Codman & Shurtleff, Inc. | 1981-11-27 | Traditional | PDF ↗ |
| K810828 | NON-INVASIVE AMPLIFIER | Henry Ford Hospital | 1981-04-10 | Traditional | PDF ↗ |
| K802686 | HP MODEL 8880A FILTER | Hewlett-Packard Co. | 1980-11-26 | Traditional | PDF ↗ |
| K802282 | ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON | Consolidated Medical Equipment, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K792283 | ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON | Arzbaecher & Co. | 1979-11-21 | Traditional | PDF ↗ |
| K791964 | MODEL 15055A MAINFRAME | Hewlett-Packard Co. | 1979-10-11 | Traditional | PDF ↗ |
| K790203 | INTERVAL TIMER MODEL V4295 | Electronics For Medicine, Inc. | 1979-03-02 | Traditional | PDF ↗ |
| K780572 | DCG PREAMPLIFIER MODULE | C-V Monitors Corp. | 1978-05-09 | Traditional | PDF ↗ |
| K780043 | ESIS MODULE | Datascope Corp. | 1978-02-13 | Traditional | PDF ↗ |
| K772132 | AMPLIFIER MODULE, 78211A ECG | Hewlett-Packard Co. | 1977-11-22 | Traditional | PDF ↗ |
| K771976 | ECG AMPLIFIER/R WAVE TRIGGER | G.D. Searle and Co. | 1977-11-09 | Traditional | PDF ↗ |
| K771572 | PATIENT MONITORS MODELS 78701A/78702A | Hewlett-Packard Co. | 1977-08-30 | Traditional | PDF ↗ |
| K770243 | ELGILOY STYLET | Cardiac Pacemakers, Inc. | 1977-02-14 | Traditional | PDF ↗ |
| K761056 | DISPLAY MONITOR (MODEL 78301A) | Hewlett-Packard Co. | 1976-12-09 | Traditional | PDF ↗ |
Product code DRR · Class II · Cardiovascular. Data: openFDA.