Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 30
- Latest Decision
- 1979-08-03
Clearances · page 61 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K791336 | BUCKS NEUROLOGICAL HAMMER | Amdia Medical Products | GWZ | Class I | 1979-08-03 |
| K791097 | CEPTORTRODE WITH CEPTOR HESIVE | Med General | GXY | Class II | 1979-08-03 |
| K791075 | H-H SLOTTED CATHETER-RESERVOIR | Holter-Hausner Intl. | JXG | Class II | 1979-08-03 |
| K790920 | INTRACRANIAL PRESSURE MONITORING | Codman & Shurtleff, Inc. | GWM | Class II | 1979-08-03 |
| K791076 | H-H SLOTTED VENTRICULAR CATHETER | Holter-Hausner Intl. | JXG | Class II | 1979-08-03 |
| K791337 | TAYLOR NEUROLOGICAL HAMMER | Amdia Medical Products | GWZ | Class I | 1979-08-03 |
| K791158 | STIMULATOR, ELECTRICAL NERVE | Electreat, Inc. | GZJ | Class II | 1979-07-03 |
| K790738 | HABITSABATER | Jackson Ent. | HCB | Class II | 1979-06-20 |
| K790818 | MEDI-TRACE EEG CREME | Graphic Controls Corp. | GYB | Class II | 1979-06-05 |
| K790850 | T.E.N.S.* SINGLE-USE ELECTRODE | 3M Company | GXY | Class II | 1979-05-31 |
| K790790 | PISCES-SELECTOR X | Medtronic Vascular | GZB | Class II | 1979-05-25 |
| K790570 | STIMULATOR, NIC-106 VISUAL | Nicolet Biomedical Instruments | GWE | Class II | 1979-05-23 |
| K790542 | ELECTRODES, STAODERM STERILE | Staodynamics, Inc. | GXY | Class II | 1979-05-23 |
| K790746 | THE BIONIC EXERCISER | Scudder Molner Instruments | HCC | Class II | 1979-05-14 |
| K790849 | H-H FIXATION AND JOINING CONNECTORS | Holter-Hausner Intl. | JXG | Class II | 1979-05-11 |
| K781493 | EEG GEL | Graphic Controls Corp. | GYB | Class II | 1979-04-17 |
| K790502 | DYONICS STEROTOXIC POSITIONER | Dyonics, Inc. | HAW | Class II | 1979-04-05 |
| K790316 | ELECTRODE, ELECTROFLEX | Andover Medical, Inc. | GXY | Class II | 1979-03-27 |
| K790345 | STIMTECH TENS ELECTRODE | Stimulation Technology, Inc. | GXY | Class II | 1979-03-21 |
| K782055 | CREAM, SIGNA | Parker Laboratories, Inc. | GYB | Class II | 1979-03-21 |
| K790413 | HEIFETZ ANEURYSM CLIP, LMM BLADE | Edward Weck, Inc. | HCH | Class II | 1979-03-16 |
| K782164 | STIMULATOR, MODEL 1-600 ELECTRIC NERVR | Ipco Corp. | GZJ | Class II | 1979-03-08 |
| K790011 | STIMULATOR, MENTOR 100 NERVE | Mentor Corp. | GZJ | Class II | 1979-03-02 |
| K790269 | CEPTOR HESIVE | Med General | GXY | Class II | 1979-02-26 |
| K790189 | ELECTREAT MODEL 250 TRANSCUTANEOUS STIM | Electreat, Inc. | GZJ | Class II | 1979-02-08 |
| K782137 | MEDTRONIC MODEL 3797 ELECTRODE | Medtronic Vascular | GXY | Class II | 1979-02-07 |
| K790217 | GENERATOR, MODEL VG-1 | Street Electronics Corp. | GWE | Class II | 1979-02-06 |
| K790126 | VALVE, H-H CRUCIFORM SLIT | Holter-Hausner Intl. | JXG | Class II | 1979-01-26 |
| K782036 | TREMOR MONITOR | Columbus Instruments Intl. Corp. | GYD | Class II | 1979-01-23 |
| K782105 | CATHETERS, H-H VENTRICULAR | Holter-Hausner Intl. | JXG | Class II | 1979-01-15 |
| K782127 | STIMULATOR, ELECTRICAL NERVE | Somatronics, Inc. | GZJ | Class II | 1979-01-05 |
| K781989 | OMNIPREP | Weaver & Co. | GYB | Class II | 1978-12-15 |
| K782075 | STIMULATOR, MODEL 7727 | Medtronic Vascular | GZJ | Class II | 1978-12-14 |
| K781704 | STIMULATOR, TN-3001 SOMATOSENSORY | Tracor Instruments, Inc. | GWF | Class II | 1978-12-01 |
| K781743 | RESPONSE SYSTEM, TN-3000 | Tracor Instruments, Inc. | GWL | Class II | 1978-12-01 |
| K781829 | NEUROPAC ULTRA II | Medical Devices, Inc. | GZJ | Class II | 1978-11-22 |
| K781768 | CATHETERS, H-H ATRIAL AND PERITONEAL | Holter-Hausner Intl. | JXG | Class II | 1978-11-14 |
| K781461 | MODEL 7320 VISUAL STIMULATOR | Life-Tech Instruments, Inc. | GWE | Class II | 1978-11-08 |
| K781670 | STIMULATOR, E.S.I. NEURO | Evolutionary Systems, Inc. | GZJ | Class II | 1978-11-07 |
| K781667 | AMPLAID MARK 4 AND MARK 5 | Amplaid USA, Inc. | GWJ | Class II | 1978-11-03 |
| K781494 | EEG LEAD ASSEMBLY | Graphic Controls Corp. | GXY | Class II | 1978-10-31 |
| K781683 | NURITE II, SINGLE | Bio-Medical Systems Corp. | GZJ | Class II | 1978-10-13 |
| K781565 | ELECTRICAL NERVE STIMULATOR MODEL 6035 | Stimulation Technology, Inc. | GZJ | Class II | 1978-10-11 |
| K781314 | THERAPY UNIT & ELECTRODIAG. | General Theraphysical, Inc. | GXY | Class II | 1978-10-03 |
| K781634 | VISUALAX | Farrall Instruments, Inc. | HCC | Class II | 1978-10-03 |
| K781277 | STIMULATOR, NERVE, TRANSCUTANEOUS | Psitron | GZJ | Class II | 1978-09-27 |
| K781290 | SIGNAL AVERAGER MODEL 4202 | Princeton Applied Research Corp. | GWK | Class II | 1978-09-15 |
| K781289 | PREAMPLIFIER MODEL 113 | Princeton Applied Research Corp. | GWL | Class II | 1978-09-14 |
| K781475 | ELECTRODE IMPEDANCE TESTER-MODEL 500 | Life-Tech Instruments, Inc. | GYA | Class I | 1978-09-07 |
| K781129 | ACCESSORY TO 4-24 RECORDER | Oxford Medilog, Inc. | GWQ | Class II | 1978-08-31 |
| K781398 | TECA VS6 VIDEO STIMULATOR | Teca, Inc. | GWE | Class II | 1978-08-23 |
| K781130 | ACCESSORY TO ECG ANALYSIS SYS. | Oxford Medilog, Inc. | OMC | Class II | 1978-08-23 |
| K781311 | ELECTRODE, NEEDLE, CFM | Applied Medical Research | GXZ | Class II | 1978-08-21 |
| K781302 | NEUROSTAT, LLOYD | Spembly Medical , Ltd. | GXH | Class II | 1978-08-15 |
| K780973 | SIGNAPAD | Parker Laboratories, Inc. | GYB | Class II | 1978-07-27 |
| K781005 | ELECTROENCEPHALOGRAPH ACCUTRATE 200 | Beckman Instruments, Inc. | GWQ | Class II | 1978-06-28 |
| K781041 | ELECTROENCEPHALOGRAPH ACCUTRACE 100 | Beckman Instruments, Inc. | GWQ | Class II | 1978-06-28 |
| K780539 | STIMULATOR MODEL 8021 | Life-Tech Instruments, Inc. | GWF | Class II | 1978-06-22 |
| K780537 | EAR ELECTRODE-ADULT & PEDIATRIC | Life-Tech Instruments, Inc. | GXY | Class II | 1978-06-02 |
| K780828 | NURITE II | Bio-Medical Systems Corp. | GZJ | Class II | 1978-05-31 |
| K780758 | NEUROLOGICAL SCREENING STIMULATOR M 3623 | Medtronic Vascular | GZB | Class II | 1978-05-19 |
| K780579 | SUBCUPASS TUNNELING TOOL | Medtronic Vascular | HAO | Class I | 1978-05-19 |
| K780520 | VAS APPROXIMATOR | Edward Weck, Inc. | HAO | Class I | 1978-05-16 |
| K780698 | STIMULATORS, NERVE, ELECTRICAL | Med General | GZJ | Class II | 1978-05-12 |
| K780436 | RELAX-A-TONE | Bio Response | HCC | Class II | 1978-05-12 |
| K780631 | NDM INFANT ECG PACKPAD | New Dimensions IN Medicine, Inc. | GYB | Class II | 1978-05-03 |
| K780540 | ELECTRIC RESPONSE AUDIOMETER | Life-Tech Instruments, Inc. | GWJ | Class II | 1978-04-21 |
| K780444 | NERVTRON-RX | Medix Corp. | GZJ | Class II | 1978-04-19 |
| K780538 | AUDIO MONITOR-MODEL 8309 | Life-Tech Instruments, Inc. | GWK | Class II | 1978-04-19 |
| K780422 | PINWHEEL | Projects IN Health | GWY | Class I | 1978-04-04 |
| K780186 | NEUROMOD STIMULATOR MODEL 3723 | Medtronic Vascular | GZJ | Class II | 1978-03-02 |
| K780045 | ELECTRODE CAP | Electro-Cap Intl., Inc. | GXY | Class II | 1978-01-24 |
| K780001 | EPIDURAL LEAD - MODEL 3481 | Medtronic Vascular | GZB | Class II | 1978-01-17 |
| K772406 | AESTHESIOMETER | Fred Sammons, Inc. | GXB | Class I | 1978-01-06 |
| K772371 | BAYONET SURGICAL INSTRUMENTS | Edward Weck, Inc. | HAO | Class I | 1978-01-06 |
| K772389 | DANDY HEMOSTATIC FORCEPS | Edward Weck, Inc. | HAO | Class I | 1978-01-06 |
| K772063 | CATHETER, INTRACRANIAL PRESS. MONITOR. | Cordis Corp. | GWM | Class II | 1978-01-03 |
| K772224 | NERVE STIMULATOR, ELEC. TRANSCUTANEOUS | Stimulation Technology, Inc. | GZJ | Class II | 1977-12-15 |
| K772200 | YASARGIL ANEURYSM CLIPS | Aesculap Instruments Corp. | HCH | Class II | 1977-12-08 |
| K771742 | EVOKED RESPONSE SYS., MODEL 10 | Grass Instrument Co. | GWK | Class II | 1977-11-22 |
| K772102 | AMPLIFIER OTRONA, MODEL N3A-EMG | Honeywell, Inc. | GWL | Class II | 1977-11-21 |
| K771885 | IMPORTED PAIN CONTROL DEVICE | Empi | GZJ | Class II | 1977-11-02 |
| K771893 | DISPOSABLE ELHCTRODE | Chase Medical Services | GYB | Class II | 1977-11-02 |
| K771847 | TEMP-TESTER | Jablecki, Charles, Dr. | GXB | Class I | 1977-11-02 |
| K772013 | PERCUPASS TUNNELING TOOL MODEL 3452 | Medtronic Vascular | HAO | Class I | 1977-10-28 |
| K771719 | KARAYA ELECTRODES | Lectec Corp. | GXY | Class II | 1977-09-20 |
| K771683 | AMPLIFIER MODEL N3B-EEG | Honeywell, Inc. | GWL | Class II | 1977-09-20 |
| K771534 | BIOTRON 18 | Biotronics Corp. | QJQ | Class II | 1977-08-26 |
| K771577 | CLINICAL EMG MODEL 133 | Calnor of EL Paseo, Inc. | HCC | Class II | 1977-08-26 |
| K771529 | PERITONEAL INTRODUCER & SHEATH | Cordis Corp. | GYK | Class I | 1977-08-16 |
| K771122 | VERI/CTGS MODEL 850 | Verite Scientific, Inc. | GZJ | Class II | 1977-08-04 |
| K771023 | ANALOG QUANTIFIER MODEL AQ-100 | Bio-Feedback Systems, Inc. | HCC | Class II | 1977-06-24 |
| K770894 | NEURO-SORB PATTIES | Instranetics, Inc. | HBA | Class II | 1977-06-20 |
| K770787 | RELAXATION COURSE MODEL 1000 | Cybernetic Medical, Inc. | HCC | Class II | 1977-06-17 |
| K770987 | NERVE STIMULATOR, MOLEL NO. FB-800 | Output, Inc. | GZI | Class II | 1977-06-14 |
| K770878 | SIGNAL PROCESSOR/AVERAGER MODEL 7S11 | Medical Systems Corp. | GWJ | Class II | 1977-06-01 |
| K770790 | FEEDBACK EDR SYSTEM MODEL EDR-100 | Bio-Feedback Systems, Inc. | HCC | Class II | 1977-05-10 |
| K770788 | ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000 | Storz Instrument Co. | GXW | Class II | 1977-05-06 |
| K770782 | FIBERSCOPIC SCOPE RECORDER SYSTEM | Elmed, Inc. | GWK | Class II | 1977-05-06 |
| K770575 | ECHOENCEPHALOGRAPH, DIGITAL, 1000 | Storz Instrument Co. | GXW | Class II | 1977-04-26 |
6,130 clearances in the Neurology panel. Data: openFDA.