meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
36
Latest Decision
1990-02-22

Clearances · page 51 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K895895 MODEL 219 TELEMETRY SYSTEM Mennen Medical, Inc. GYE Class II 1990-02-22
K900059 BIOPOTENTIAL SURFACE ELECTRODE Integral Design, Inc. GXY Class II 1990-02-22
K900063 MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA) Bio-Feedback Systems, Inc. GWL Class II 1990-02-16
K896567 CANTATA EMG/EVOKED RESPONSE SYSTEM Dantec Medical, Inc. GWF Class II 1990-02-16
K896666 P460, DG32 ELECTROENCEPHALOGRAPH Teca, Inc. GWQ Class II 1990-02-16
K896844 BABE-EASE NEONATAL CLOTH ECG ELECTRODE Labeltape Meditect, Inc. GXY Class II 1990-02-12
K883911 ELECTRO-ACUSCOPE 85 Biomedical Design Instruments GZJ Class II 1990-02-02
K894155 SLEEPSCAN Biologic Systems Corp. OLZ Class II 1990-01-26
K896164 ASC-954 INTEGRATOR AMPLIFIER Astro-Med, Inc. GWK Class II 1990-01-22
K896936 L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAP Labeltape Meditect, Inc. GXY Class II 1990-01-22
K885120 ESI MODEL MS-103 Electrical Systems Div. GZT Class II 1990-01-19
K895289 MEC-I-TRON MINI, MODEL M-2 Meyer Equipment Company, Inc. GZJ Class II 1990-01-19
K895183 REBOX II (TENS) Rebox (Uk) , Ltd. GZJ Class II 1990-01-19
K894510 BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH Capscan Corp. HCC Class II 1990-01-16
K895977 ACUSOURCE 600 (TENS) Microcurrent Research, Inc. GZJ Class II 1990-01-09
K894964 K-2 TENS OR MED TENS Oms Medical Supplies, Inc. GZJ Class II 1990-01-04
K890500 ELT OR ERGONOMIC LIFT TRAINER Physical Health Devices, Inc. HCC Class II 1990-01-03
K894608 MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM Micro-Shev , Ltd. GWF Class II 1989-12-29
K895125 CEEGRAPH Bio-Logic Systems Corp. GWQ Class II 1989-12-22
K894889 TECA NEUROMAPPER 386 Teca, Inc. OLT Class II 1989-12-22
K894044 ACTILLUME Ambulatory Monitoring, Inc. GWQ Class II 1989-12-22
K896370 DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45) Chalgren Enterprises, Inc. GXZ Class II 1989-12-22
K893874 FUJITENS III Altoona Medical Supply GZQ Class II 1989-12-22
K896485 MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN Empi GXY Class II 1989-12-21
K896167 PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR Pudenz-Schulte Medical Research Corp. JXG Class II 1989-12-21
K896745 JAW BLOCKER Plastic Engineered Products Co. JXL Class II 1989-12-14
K892649 VERIMED MYOEXORCISER III (MYO III) Verimed Holdings, Inc. HCC Class II 1989-12-13
K895473 DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S Medical Devices, Inc. GZJ Class II 1989-12-08
K896156 COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM Stereotactic Medical Systems, Inc. GZT Class II 1989-12-06
K894778 CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER Codman & Shurtleff, Inc. HBO Class II 1989-12-06
K893793 TENZCARE ELECTRODE 6862 3M Company GXY Class II 1989-11-27
K893395 MINI-MONITOR J7000 ICP Ladd Research Industries, Inc. GWM Class II 1989-11-22
K893604 TENS PREP Smith & Nephew United, Inc. GYB Class II 1989-11-21
K894088 TECA NEUROMAPPER 1620, BRAIN MAPPER Teca, Inc. OLT Class II 1989-11-15
K895081 PROMONTORY STIMULATING ELECTRODE Cadwell Laboratories, Inc. GXY Class II 1989-11-09
K895175 NF-1 MINDPEACE Neurofitness QJQ Class II 1989-11-08
K894387 WESTCO MADAYAG PAB NEEDLE Western Medical, Ltd. HAW Class II 1989-11-07
K895295 ULTIMA XS MICROCURRENT TENS American Imex GZJ Class II 1989-11-06
K895868 HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE Baxter Healthcare Corp GYK Class I 1989-10-31
K883914 FATIGMETER K. Jimbo Co., Inc. GWE Class II 1989-10-31
K895334 TTS2600 Henley Intl. GZJ Class II 1989-10-30
K895166 TTS2500 Henley Intl. GZJ Class II 1989-10-30
K895161 TTS2800 Henley Intl. GZJ Class II 1989-10-30
K895211 TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR Henley Intl. GZJ Class II 1989-10-30
K883811 ELECTRONIC PAIN RELIEVERS Jetco of America GZJ Class II 1989-10-24
K890981 ELECTRO-TOUCH (ET) GLOVE Psychoenergetic Systems, Inc. GXY Class II 1989-10-19
K895395 V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR Baxter Healthcare Corp GZT Class II 1989-10-19
K892114 ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM Eclosion, Inc. HCC Class II 1989-10-13
K895604 SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES Medical Design & Manufacturing Corp. GXY Class II 1989-10-13
K895739 MICROMEDICS SURGICAL DRILL SYSTEM Micromedics, Inc. HBB Class II 1989-10-13
K894840 MYODAC2 BIOFEEDBACK DEVICE Thought Technology , Ltd. HCC Class II 1989-10-13
K891992 TENZCARE STIMULATOR 6890 3M Company GZJ Class II 1989-10-12
K894772 THERMALGRAPHIC ANALYSER Medtech Instruments HCS Class II 1989-10-03
K894276 CADWELL FREEDOM EEG DEVICE Cadwell Laboratories, Inc. GWQ Class II 1989-09-29
K894097 NTI-1000 Neurotek, Inc. QJQ Class II 1989-09-25
K891688 COIL AND COIL DELIVERY SYSTEM Target Therapeutics HCG Class II 1989-09-22
K895537 MODIFIED MEMORY RETRACTOR ARM Medical Equipment Development Co., Inc. GZT Class II 1989-09-22
K890087 ACUDATA INDICATENS MODEL 5M Acudata Software GZJ Class II 1989-09-07
K891118 STERLING TENS Armstrong Industries, Inc. GZJ Class II 1989-09-06
K894127 LUMISCOPE MODEL 1000/APCC MODEL 1000 Lumiscope Co., Inc. GZJ Class II 1989-09-06
K893216 RMI ULTRASOUND DOPPLER PHANTOM SYSTEM Radiation Measurements, Inc. GXX Class I 1989-09-05
K894263 CASS SYSTEM Medical Instrumentation & Diagnostics Corp.(Midco) HAW Class II 1989-09-01
K893911 MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM Medical Equipment Development Co., Inc. HBL Class II 1989-08-29
K892215 UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT Codman & Shurtleff, Inc. JXG Class II 1989-08-21
K891693 AUTOMATED THERAPY SYSTEM Harding & Harris, Inc. HCC Class II 1989-08-21
K894042 SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS Labeltape Meditect, Inc. GXY Class II 1989-08-11
K894043 SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS Labeltape Meditect, Inc. GXY Class II 1989-08-11
K894388 ZIMMER TENS American Imex GZJ Class II 1989-08-10
K883112 DERMATRON SKIN RESISTANCE METER Raymar Electronics GZO Class II 1989-08-10
K894072 THE PUDENZ IN LINE VALVE Baxter Healthcare Corp JXG Class II 1989-08-07
K892884 MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION Medtronic Vascular GZB Class II 1989-08-07
K891405 BMS-2000 MOBILE EEG SYSTEM Buckman Co., Inc. GYE Class II 1989-08-02
K891920 AD-TECH'S DEPTH ELECTRODE Ad-Tech Medical Instrument Corp GZL Class II 1989-07-27
K884972 TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR Futuremed Div. of Future Impex Corp. GZJ Class II 1989-07-27
K883896 NEUROTRAIN Sterne Equipment Co., Ltd. LIH Class II 1989-07-14
K891456 HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM Baxter Healthcare Corp JXG Class II 1989-06-23
K892408 NSD 8CS8 - TENS DEVICE Future Medical Products, Inc. GZJ Class II 1989-06-23
K892866 AUTOMATIC CRANIAL DRILL (PERFORATOR) Acra Cut, Inc. HBF Class II 1989-06-15
K890443 CASPAR SCALP CLIP, APPLIER Aesculap Instruments Corp. HBO Class II 1989-06-15
K884869 MODIFIED MRL NEUROPROBE SYSTEM V Medical Research Laboratories, Inc. GZJ Class II 1989-06-06
K891383 MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM Oxford Medilog, Inc. OLZ Class II 1989-06-01
K890604 EMPI, MODEL 489, TENS Empi GZJ Class II 1989-06-01
K890088 ACUDATA INDICATENS MODEL 5X Acudata Software GZJ Class II 1989-05-26
K891105 INDICATENS MODEL 4X4 SP ELECTRODE STIM. PATCHES Acudata Software GXY Class II 1989-05-25
K891107 INDICATENS INDICATOR ELECTRODE MODEL 2 Acudata Software GXY Class II 1989-05-25
K883462 IF-II (TM), MODEL 9800 Medical Devices, Inc. LIH Class II 1989-05-24
K890274 MEM-7102; MEB-7102 EVOKED RESPONSE & ELECTRO RECOR Nihon Kohden America, Inc. GWF Class II 1989-05-18
K892546 TAYLOR SPINAL RETRACTOR Zinnanti Surgical Instruments, Inc. HAO Class I 1989-05-11
K892535 NEUROLOGICAL RONGEURS - VARIOUS TYPES Zinnanti Surgical Instruments, Inc. HAE Class II 1989-05-11
K892543 NEUROSURICAL RETRACTORS - VARIOUS TYPES Zinnanti Surgical Instruments, Inc. GZT Class II 1989-05-05
K892531 NEUROSURGICAL DRILLS: STILLE, HUDSON Zinnanti Surgical Instruments, Inc. HBG Class II 1989-05-05
K890513 SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS) Micro Tronics Corp. OLZ Class II 1989-04-28
K883080 SYS*STIM 220 Mettler Electronics Corp. LIH Class II 1989-04-27
K885190 MICRO-STIM 200 Theri-Teck, Inc. GZJ Class II 1989-04-26
K890468 MODEL FT-100 INTRACRANIAL PRESSURE MONITOR Pearl Instruments Corp. GWM Class II 1989-04-26
K882980 REBUILDER BUCKET SYSTEM Micromed, Inc. GZJ Class II 1989-04-24
K881164 LEUNOMED RFB 5000 Hemodynamics, Inc. HCC Class II 1989-04-24
K891571 PERCUSSION HAMMER Sandal Surgico GWZ Class I 1989-03-31
K890881 TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS Teca, Inc. GWQ Class II 1989-03-23
K884849 BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR Moe HCC Class II 1989-03-23

6,130 clearances in the Neurology panel. Data: openFDA.