meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
31
Latest Decision
1983-11-28

Clearances · page 58 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K833354 AUTO-TENS MODEL VI DUAL CHANNEL BATT Physio Tronics Corp. GZJ Class II 1983-11-28
K833305 VECTOR SEIGE 2023645 AC POWERED STIMU- Metronex Engineering LIH Class II 1983-11-28
K833413 COMPUTERSCOPE CPS-ABR Rc Electronics, Inc. GWL Class II 1983-11-28
K832510 EVOKED POTENTIALS SYSTEM MK10 Amplaid USA, Inc. GWJ Class II 1983-11-25
K832795 HEIFETZ INTRACRANIAL ANEURYSM CLIPS Edward Weck, Inc. HCH Class II 1983-11-25
K833172 ECG-GEL ELECTRODE GEL Whs Products, Inc. GYB Class II 1983-11-21
K832160 ELECTRO-PULSE Electro-Pulse GZJ Class II 1983-11-14
K832442 ELECTRO-ACUSCOPE Kenneth J. Purcell GZJ Class II 1983-10-31
K832714 VERIMED MYOEXORCISER Verimed Holdings, Inc. HCC Class II 1983-10-28
K831487 ELECTRONEURAL STIMULATOR 12 Meridia 12 Corp. GZJ Class II 1983-10-28
K832851 AGAR 8000 TENS Kimed Industries, Inc. GZJ Class II 1983-10-28
K832067 SHARE INT'L TDM Share Int'L HCJ Class II 1983-10-27
K831651 EVOKED POTENTIAL SYSTEM 2000 Ophthalmetric Corp. GWE Class II 1983-09-12
K832333 FEEDBACK EMG SYSTEM PE-020 Bio-Feedback Systems, Inc. HCC Class II 1983-09-01
K832295 S2MEDIAN Anstek Corp. GXY Class II 1983-08-31
K832304 BRAEGEN III 10-CHANNEL TRANSMITTER- Electro-Bio-Medical Services, Inc. GYE Class II 1983-08-31
K832296 S2 POSTERIOR-TIB Anstek Corp. GXY Class II 1983-08-31
K832238 NEUROMOD COMFORT WAVE #7721 DUAL- Medtronic Vascular GZJ Class II 1983-08-31
K832337 AUTO-TENS MODEL V Cbc Corp. GZJ Class II 1983-08-31
K832146 TA-400 TEMP. FEEDBACK DEVICE Spectral Data Systems HCC Class II 1983-08-16
K832084 EVOKED 3500 POTENTIAL SYSTEM Tracor Northern, Inc. GWE Class II 1983-08-16
K831963 CRYOMEDICS NEUROSTAT Spembly Medical , Ltd. GXH Class II 1983-08-12
K831396 P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT Pudenz-Schulte Medical Research Corp. JXG Class II 1983-08-12
K832343 DERMALAND DURAL HOOKS National Fabtronix, Inc. HAO Class I 1983-08-12
K830992 XCEL MODEL XE-1 Electrocaine Medical System GZJ Class II 1983-08-12
K832122 ENRAF NONIVS2 CHANNEL EMG/TEMP. FEED Fluidotherapy Corp. HCC Class II 1983-08-12
K831746 PISCES #3487 EPIDURAL LEAD FOR SPINAL Medtronic Vascular GZB Class II 1983-08-11
K831995 TRENDO-SCOPE Gabriel Ent. HCS Class II 1983-08-08
K831950 PULSAR #B SINGLE CHANNEL TENS-PULSAR D Spembly Medical , Ltd. GZJ Class II 1983-08-01
K831896 COMPACT FOUR Nicolet Biomedical Instruments GWF Class II 1983-07-28
K832145 MONOBLOCK PROSTOPERATIVE TENS ELECTRODE New Dimensions IN Medicine, Inc. GXY Class II 1983-07-19
K831850 NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE Th Charters, Inc. GZJ Class II 1983-07-19
K831147 OMNIPROBE ELECTRICAL NERVE STIMULATOR Omni Intl., Inc. GZJ Class II 1983-07-18
K830999 DAP II BIOPSY GUIDE Rapid Machine & Tool Corp. HAW Class II 1983-07-12
K831145 ALPHA-STIM 350 Electromedical Products, Inc. GZJ Class II 1983-07-07
K831785 NEURO EASE Andover Medical, Inc. GXY Class II 1983-06-30
K831144 ALPHA-STIM 2000 Electromedical Products, Inc. GZJ Class II 1983-06-30
K831678 P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR Pudenz-Schulte Medical Research Corp. JXG Class II 1983-06-24
K831329 PMT VAXIOM STEREOTACTIC SYS #FX001 Progress Mankind Technology HAW Class II 1983-06-15
K831413 SPEC IISX Medical Devices, Inc. GZJ Class II 1983-06-08
K831071 UNIVERSAL INSTRU. SET FOR NEUROVASCULAR Prothia USA, Inc. GZX Class I 1983-06-08
K830877 AP-CHECK General Devices GYA Class I 1983-06-08
K830747 PC 2909A-HEALTH PULSE CONTROL STIMULATOR J.A. Preston Corp. GZJ Class II 1983-05-30
K831324 EEG 42/2P ELECTRO ENCEPHALOGRAPH Nihon Kohden America, Inc. GWQ Class II 1983-05-27
K831047 BIOLOGIC SYSTEM BL 101 Bio-Logic Systems Corp. GWE Class II 1983-05-13
K831104 TENZCARE MUSCLE STIMULATION ELECTRODES 3M Company GXY Class II 1983-05-09
K823790 VENTRICULAR ACCESS SYSTEM American Heyer Schulte LKG Class II 1983-04-28
K831046 ELECTRODE 3799 Medtronic Vascular GXY Class II 1983-04-26
K830932 NYNEX II La Jolla Technology, Inc. GZJ Class II 1983-04-18
K830771 CADWELL 8400 Cadwell Laboratories, Inc. GWF Class II 1983-04-12
K830894 H-H IN-LINE VALVED CATHETER 2 TYPES Holter-Hausner Intl. JXG Class II 1983-04-08
K830798 STERILE SURGICAL PAIN RELIEF ELECTRODE Lectec Corp. GXY Class II 1983-04-05
K823511 EMG BIOFEEDBACK DEVICE Nemectron Medical, Inc. HCC Class II 1983-03-31
K830792 PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE Bomed Medical Mfr., Ltd. GZJ Class II 1983-03-29
K830597 BABY CAP, ELECTRODE SET & BOARD ADAPTOR Precision Cap Systems GXY Class II 1983-03-24
K830602 PRECISION CAP STRAPS Precision Cap Systems GXY Class II 1983-03-24
K830295 MEDILOG 9000 SYSTEM Oxford Medilog, Inc. GWQ Class II 1983-03-24
K830529 BIOFEEDBACK-TRAINING INSTRUMENT Relaxomat, Inc. HCC Class II 1983-03-24
K830601 FOAMIES DIAPOS. FOAM RUBBER PADS Precision Cap Systems GXY Class II 1983-03-24
K830598 EVOKED POTENTIAL CAP W/EVOKED POTENTIAL Precision Cap Systems GXY Class II 1983-03-24
K830600 REFERENCE & MONITORING ELECTRODE Precision Cap Systems GXY Class II 1983-03-24
K830521 PRECISION EEG CAP W/ELECTRODE SET AND Precision Cap Systems GXY Class II 1983-03-24
K830599 LOCALIZING ELECTRODE Precision Cap Systems GXY Class II 1983-03-24
K823424 MENISCECTOMY TRAY #9715 Concept, Inc. HAW Class II 1983-03-17
K823503 P-S CSF-VENTRICULAR CATHETER, FLANGED Pudenz-Schulte Medical Research Corp. JXG Class II 1983-03-09
K830579 MULTI-SIGNAL AUDITORY STIMULATOR SM700 Nicolet Biomedical Instruments GWJ Class II 1983-03-08
K823466 AUTO-TENS MODEL III DUAL CHANNEL REPLACE Cbc Corp. GZJ Class II 1983-03-07
K830332 BUDDE-HALO RETRACTOR Ohio Medical Instrument Co., Inc. GZT Class II 1983-03-02
K830325 TIGER PULSE Bertone & Assoc. GZK Class II 1983-03-01
K830191 NEURO DIAGNOSTICS MODEL FCR Neurodiagnostics, Inc. GWK Class II 1983-02-18
K830090 DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR Hudson Oxygen Therapy Sales Co. JXL Class II 1983-02-07
K823467 AUTO-TENS MODEL I DISPOS. SINGLE CHAN Cbc Corp. GZJ Class II 1983-02-07
K823464 AUTO-TENS MODEL IV -DUAL CHANNEL FULL Cbc Corp. GZJ Class II 1983-02-02
K823465 AUTO-TENS MODEL II SINGLE CHANNEL Cbc Corp. GZJ Class II 1983-02-02
K822268 NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH Kelleher Corp. GWN Class II 1983-01-28
K823742 NEUROMOD COMPLEMENT #7724 DUAL CHANNEL Medtronic Vascular GZJ Class II 1983-01-21
K823194 SKIN GALVANOMETER Spelson Research Laboratories, Inc. HCJ Class II 1983-01-21
K823497 WRIGHT CARE Dow Corning Wright GZJ Class II 1983-01-07
K823675 FRONING GUIDANCE SYSTEM #TX-8200 Today'S Machining & Design, Inc. HAW Class II 1983-01-05
K823381 PROFESSIONAL MARK I BIOFEEDBACK SYS Srs Co. HCC Class II 1983-01-05
K823459 PHILLY BOLT ADULT PROCEDURE KIT Philadelphia Medical Specialties GWN Class II 1982-12-22
K823509 P-S MED. LUMBO PERITONEAL & VENTRICULO- Pudenz-Schulte Medical Research Corp. JXG Class II 1982-12-16
K823299 MODEL 402P SEQUENCER FOR EMPI TEMS DEV Epmi, Inc. GZJ Class II 1982-12-15
K823530 STIMUCORD EXTERNAL NEURAL STIM. 911A Cordis Corp. GZB Class II 1982-12-15
K821736 ECHO-PULSE KM555 Rabar, Inc. GXW Class II 1982-12-09
K823116 NEUROTRAC Interspec, Inc. GWQ Class II 1982-12-07
K823140 ELECTROENCEPHALOGRAPH Nihon Kohden America, Inc. GWQ Class II 1982-12-07
K823146 CALMSET 3 TM Thought Technology , Ltd. HCC Class II 1982-12-03
K822885 HALO TRACTION CERVICAL IMMOBILIZATION Orthopedic Systems, Inc. HAX Class II 1982-11-22
K822929 VERIL/PPR PERSONAL PAIN RELIEVER #800 Verite GZJ Class II 1982-11-17
K823002 DENDRITE VM-TRANSCUTANEOUS ELEC. NERVE Tri W-G, Inc. GZJ Class II 1982-11-17
K822864 INTRACRANIAL PRESSURE MONITORING DEVICE Medex, Inc. GWM Class II 1982-11-16
K822841 THE EMD TENZ PAIN CONTROL SYSTEM Electro Medical Development GZJ Class II 1982-11-16
K822744 #ST10 PROGR. EVOKED RESPONSE STIMULATOR Teca, Inc. GWF Class II 1982-11-03
K822854 PRO MED 100 Rebco Trading Co. GZJ Class II 1982-10-15
K822814 EMG 100T Thought Technology , Ltd. HCC Class II 1982-10-08
K822795 GABRIEL DIGITREND Gabriel Ent. HCS Class II 1982-10-08
K822700 DEL MAR MODEL 5500 EEG SCANNER Del Mar Avionics GWQ Class II 1982-10-04
K821772 SURGITA/MIZHO MICRONEUROSURGERY HEAD FR Downs Surgical , Ltd. HBL Class II 1982-09-28
K822214 CADWELL 7400 Cadwell Laboratories, Inc. GWF Class II 1982-09-24

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