meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
35
Latest Decision
1987-07-21

Clearances · page 54 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K871722 MEDTENS(TM), MODEL NUMBER 7725 Medtronic Vascular GZJ Class II 1987-07-21
K872183 AMBULATORY EEG PLAYBACK Cadwell Laboratories, Inc. GWQ Class II 1987-07-21
K871678 NICOLET AMP 6R11 SYSTEM Nicolet Biomedical Instruments GWL Class II 1987-07-16
K872044 CARBON ELECTRODE Futuremed Div. of Future Impex Corp. GXY Class II 1987-07-16
K871913 CONDUCTIVITY GEL Futuremed Div. of Future Impex Corp. GYB Class II 1987-07-15
K872045 CONDUCTIVITY GEL Futuremed Div. of Future Impex Corp. GYB Class II 1987-07-15
K871500 MODEL 5000 AMBULATORY MONITORING SYSTEM Oxford Medilog, Inc. GWQ Class II 1987-07-01
K871666 MODEL HP (OR MODEL 1001) TRANSCUTANEOUS STIMULATOR Oriental Medical Supplies, Inc. GZJ Class II 1987-06-25
K871699 TX-3(TENS) Oms Medico, Inc. GZJ Class II 1987-06-25
K871663 PMT TRACTION TONGS Progress Mankind Technology HAX Class II 1987-06-19
K871571 NEUROTIPS(TM) Ulster Scientific, Inc. GXB Class I 1987-06-18
K871685 HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS American V. Mueller JXG Class II 1987-06-12
K871396 ACCULATOR 287EP Accu Science Corp. GZJ Class II 1987-06-11
K871126 ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C Biomedical Life Systems, Inc. GZJ Class II 1987-06-02
K863815 ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000 Elcot, Inc. QGH Class II 1987-06-02
K871292 HEALTH CONCEPTS CONDUCTIVE MEMBRANE Health Concepts, Inc. GXY Class II 1987-06-02
K871125 ELECTRO-NERVE STIMULATOR TENS MODEL B5/SKN Biomedical Life Systems, Inc. GZJ Class II 1987-06-02
K871222 TANTONE MULTI-DAY #633 TENS ELECTRODE Uni-Patch, Inc. GXY Class II 1987-05-29
K871158 SIBIS REMOTE ACTUATOR Human Technologies, Inc. HCB Class II 1987-05-29
K871752 CSF-CARDIAC/PERITONEAL CATHETER Pudenz-Schulte Medical Research Corp. JXG Class II 1987-05-22
K871047 RADIOPAQUE SPHERICAL EMBOLI (RSE) Interventional Therapeutics Corp. HCG Class II 1987-05-22
K870432 A1-A2 AMBULATORY EEG CASSETTE RECORDER Grass-Telefactor Product Group GWQ Class II 1987-05-08
K871046 COMPASS STEREOTACTIC POSITIONING SYSTEM Stereotactic Medical Systems, Inc. HAW Class II 1987-05-08
K870660 H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS Holter-Hausner Intl. JXG Class II 1987-05-01
K870793 SELF REGULATION SYS PROF SERIES BIOFEEDBACK DEVICE Self Regulation Systems, Inc. HCC Class II 1987-05-01
K871480 STD-228 SPECTRAL TREND DISPLAY Grass-Telefactor Product Group GWS Class I 1987-05-01
K871120 M10 EEG MONITOR SCOPE Telediagnostic Systems, Inc. GYE Class II 1987-05-01
K870666 OMEGA T100 Henley Intl. GZJ Class II 1987-04-22
K861950 THE FM-212A BIOFEEDBACK UNIT Hosa Technology, Inc. HCC Class II 1987-04-22
K871026 DISPOSABLE, PIN-CONN. POLYMER-GEL ELECT. FOR TENS Labeltape Meditect, Inc. GXY Class II 1987-04-22
K870667 OMEGA T200 Henley Intl. GZJ Class II 1987-04-22
K864370 DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR) Dynatronics Laser Corp. GZJ Class II 1987-04-10
K870263 NEUROMAPPER 1620 Neuroscience, Inc. GWQ Class II 1987-04-10
K870450 SZAC-16 SEIZURE ANALYSIS COMPUTER Grass-Telefactor Product Group OMB Class II 1987-04-08
K870168 EMPI LOGIX MODEL 712 NMS, TENS Empi GZJ Class II 1987-04-01
K870160 DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS La Jolla Technology, Inc. GXY Class II 1987-04-01
K871167 SENSITESTER Dexin Pty. , Ltd. GWY Class I 1987-04-01
K864114 TENS DEVICE FOR RELIEF OF CHRONIC PAIN Futuremed Div. of Future Impex Corp. GZJ Class II 1987-04-01
K864928 BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER Bio-Scan, Inc. GWQ Class II 1987-03-31
K870381 DD-VCR-64 Grass-Telefactor Product Group GWK Class II 1987-03-25
K862454 AGAR 7K TENS INSTRUMENT Solcoor, Inc. GZJ Class II 1987-03-25
K863424 COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE Micromedical Technologies, Inc. GWN Class II 1987-03-23
K870583 NEU-PULS(TENS) MODEL #295 Oms Medico, Inc. GZJ Class II 1987-03-17
K865063 UNI-PULS(TENS) MODEL #292 Oms Medico, Inc. GZJ Class II 1987-03-17
K864968 BACPAC (TM), MODEL 6500 Medical Devices, Inc. GZJ Class II 1987-03-13
K870030 THE SCREENER GSI 55 ABR SCREENER Grason-Stadler, Inc. GWJ Class II 1987-03-13
K862766 EPISON, ALERTING SYSTEM FOR EPILEPTICS Zygo Industries, Inc. LEL Class II 1987-03-13
K864956 DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA. La Jolla Technology, Inc. GZJ Class II 1987-03-09
K870399 SELVERSTONE CLAMP SALIBI CLAMP Codman & Shurtleff, Inc. HCE Class II 1987-03-06
K863783 HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM Hzi Research Center OLT Class II 1987-03-03
K862820 LADD/STERITEK ICP MONITOR, CAT. NO. P3000 Ladd Research Industries, Inc. GWM Class II 1987-02-26
K864368 SCHULDT* PLUS 8 T.E.N.S. DEVICE Schuldt Laboratories, Inc. GZJ Class II 1987-02-26
K865048 ECLIPSE+, MODEL NUMBER 7723 Medtronic Vascular GZJ Class II 1987-02-26
K863469 CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA. Cordis Corp. GZJ Class II 1987-02-20
K864735 A-TENS - MODEL AI-87 American Imex GZJ Class II 1987-02-20
K864962 OBERTO MOUTH PROP Medovations, Inc. JXL Class II 1987-02-19
K862352 ACCULATOR 487E Accu Science Corp. GZJ Class II 1987-02-04
K862906 TECA/MEDELEC AS-10 SENSOR Teca, Inc. GWJ Class II 1987-02-04
K863156 TECA/MEDELEC AUDIOSTAR Teca, Inc. GWJ Class II 1987-02-03
K863985 EVOPORT 100 Jedmed Instrument Co. GWJ Class II 1987-01-29
K864345 NTE-2 THERMAL SENSITIVITY TESTER Sensortek, Inc. LQW Class I 1987-01-29
K861069 TECA NEUROPTO WITH OS-5 STIMULATOR Teca, Inc. GWE Class II 1987-01-27
K864973 TENZCARE(TM) SNAP ELECTRODE 6867 3M Company GXY Class II 1987-01-20
K863175 EES 10 ELECTRODELESS ELECTRICAL STIMULATOR Cadwell Laboratories, Inc. GWF Class II 1987-01-13
K865075 H-H SUBGALEAL TROCAR Holter-Hausner Intl. GYK Class I 1987-01-13
K864676 HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM American V. Mueller JXG Class II 1986-12-29
K862602 AXION IV GOLDLINE SERIES Ventura Medical Electronics GZJ Class II 1986-12-22
K864032 EM TENS WINDOW ELECTRODES Electromed Intl., Ltd. GXY Class II 1986-12-22
K864746 BREMER HALO SYSTEM Bremer Orthopedics HAX Class II 1986-12-22
K860910 V100 VISUALLY EVOKED POTENTIAL MONITOR New Potentials, Inc. GWE Class II 1986-12-18
K862907 P-S MEDICAL CSF-SIPHON CONTROL DEVICE Pudenz-Schulte Medical Research Corp. JXG Class II 1986-12-03
K863607 VIBRATRON II, VIBRATION SENSITIVITY TESTER Sensortek, Inc. LLN Class I 1986-12-03
K863193 SENTINEL 4 EEG ANALYZER Axon Systems, Inc. GWQ Class II 1986-12-02
K862450 MEDA 2500 T.E.N.S. Watlow/Winona, Inc. GZJ Class II 1986-11-25
K862690 TRAVELER LT Bio-Logic Systems Corp. GWF Class II 1986-11-25
K860801 MODEL 8400 W/MODIFICATIONS (SPECTRUM 32) Cadwell Laboratories, Inc. GWE Class II 1986-11-18
K863124 MODEL 8 EEG PREAMPLIFIER Micro Tronics Corp. GWQ Class II 1986-11-18
K863956 MACULOSCOPE(TM) Doran Instruments, Inc. GWE Class II 1986-11-13
K862799 SKIN PURE Nihon Kohden America, Inc. GYB Class II 1986-11-13
K860467 ELECTROSHOCK UNIT NEUROLOGY MODEL B-25 Medcraft Corp. QGH Class II 1986-11-10
K864181 SOMATICS MOUTH GUARD (BITE BLOCK) Somatics, Inc. JXL Class II 1986-11-03
K863568 'MYOSTIM EX' Electro Therapeutic Devices, Inc. GZJ Class II 1986-10-24
K863567 'TENSAID' Electro Therapeutic Devices, Inc. GZJ Class II 1986-10-24
K863479 MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL Medical Measurements, Inc. GWM Class II 1986-10-14
K861884 NEUROSCOPE SEEG Siegen Corp. GWO Class II 1986-10-14
K862915 MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 CHANNEL) Neuromed, Inc. GZB Class II 1986-10-06
K863749 TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH Teca, Inc. GWQ Class II 1986-10-06
K853770 CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT Codman & Shurtleff, Inc. GWM Class II 1986-10-06
K862527 SLEEP ANALYZING COMPUTER Micro Tronics Corp. OLZ Class II 1986-10-06
K862377 QMED SELF ADHERING ELECTRODE Qmed, Inc. GXY Class II 1986-09-26
K862430 SIEGEN HEADPHONES Siegen Corp. GWJ Class II 1986-09-26
K863650 QUANTIMAP III Quantified Signal Imaging, Inc. OLT Class II 1986-09-26
K861039 OMNIVAC (VACUUM ELECTRODE SYSTEM) Physio Technology, Inc. LIH Class II 1986-09-26
K863415 RAYLOR BONE IMPACTORS Cedar Surgical, Inc. HAO Class I 1986-09-24
K863416 RAYLOR MINI-PROBE Cedar Surgical, Inc. HAO Class I 1986-09-24
K863307 TENZCARE SNAP ELECTRODE, NO. 6865 3M Company GXY Class II 1986-09-23
K863035 POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER Valleylab, Inc. GXY Class II 1986-09-18
K862361 40-HZ AUDITORY EVOKED RESPONSE TEST Cadwell Laboratories, Inc. GWJ Class II 1986-09-17
K862363 INSERT EARPHONES Cadwell Laboratories, Inc. GWJ Class II 1986-09-17
K861895 UNI-TENS Solcoor, Inc. GZJ Class II 1986-09-09

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