meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
35
Latest Decision
1992-12-03

Clearances · page 48 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K920266 TENS MODEL 240Z Oms Medical Supplies, Inc. GZJ Class II 1992-12-03
K924545 MICRO MODE-TRANS ELECTRICAL NEURAL STIMULATOR Mod Mode Medical GZJ Class II 1992-12-01
K922064 MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE Cardiotronics, Inc. GXD Class II 1992-12-01
K912210 PRO-CHILL STIMPACK Tko, Inc. GXY Class II 1992-11-27
K923303 SAPPHIRE PREMIERE Medelec , Ltd. GWF Class II 1992-11-24
K923315 NICOLET ARK SYSTEM Nicolet Instrument Corp. GWF Class II 1992-11-23
K924348 AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC Ad-Tech Medical Instrument Corp HAW Class II 1992-11-23
K914920 BIOFEEDBACK SYSTEM/3 Davicon, Inc. HCC Class II 1992-11-16
K922529 POWERED MUSCLE STIMULATOR M.S.P. , Ltd. LIH Class II 1992-11-16
K923567 MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD Medtronic Vascular GZB Class II 1992-11-05
K921927 NICOLET VOYAGEUR Nicolet Instrument Corp. GWQ Class II 1992-11-05
K922548 MEDELEC 2110 AND 2114 EEG Medelec Intl. Corp. GWQ Class II 1992-11-03
K921560 VIBROTACTILE TESTER, MODEL NO. VTT-100 Topical Testing, Inc. LLN Class I 1992-10-30
K921936 CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR Cordis Corp. JXG Class II 1992-10-30
K915856 SENSORMEDICS 4000 SERIES SLEEP SYSTEM Sensor Medics Corp. OLZ Class II 1992-10-26
K923934 TX-3 SD Skylark Device Co., Ltd. GZJ Class II 1992-10-23
K923803 AD-TECH SUB DURAL ELECTRODEDS Ad-Tech Medical Instrument Corp GYC Class II 1992-10-23
K921485 LA MONT VIDEO PATIENT MONITORING SYSTEM Medical Systems Corp. GWQ Class II 1992-10-22
K923935 SD-605 SD II PROGRAM Skylark Device Co., Ltd. GZJ Class II 1992-10-15
K922299 ZEPPELIN MOTOR DRILL SYSTEM Von Zeppelin Chirurgische Instrumente GmbH HBE Class II 1992-10-13
K923298 MICRO 100,200,300, & 400 TENS Skylark Device Co., Ltd. GZJ Class II 1992-10-13
K920260 INTELECT 600MP Chattanooga Group, Inc. GZJ Class II 1992-10-13
K922690 PAIN-EEZ International Center For Nutritional Research GZJ Class II 1992-10-13
K921679 K-DISPERSE Katecho, Inc. GZJ Class II 1992-10-06
K923255 Q-SD Quantitative Medicine, Inc. GZJ Class II 1992-10-05
K923665 REUSABLE DUAL DISC BAR RECORDING ELECTRODES Chalgren Enterprises, Inc. JXE Class II 1992-10-05
K921863 SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS Hewlett-Packard Co. GXW Class II 1992-09-28
K921828 TEAM-MC II Henley Intl. GZJ Class II 1992-09-22
K922020 ENDOMED 582 Henley Intl. LIH Class II 1992-09-22
K922272 YASARGIL ANEURYSM CLIPS Aesculap, Inc. HCH Class II 1992-09-15
K915100 BRINDLEY & SMITH ET-1000 Zmi Corp. LIH Class II 1992-09-14
K921813 MED-TENS Ems Dist. GZJ Class II 1992-09-11
K921504 REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS Chalgren Enterprises, Inc. JXE Class II 1992-09-11
K915858 MYOTRAC2 Thought Technology , Ltd. HCC Class II 1992-09-09
K915859 MYOTRAC/S, MYODAC/S Thought Technology , Ltd. HCC Class II 1992-09-09
K921491 MEDI-STIM Mid-Canada Medical LIH Class II 1992-09-03
K923027 NEURAY SURGICAL PATTIES AND STRIPS Martland Healthcare, Inc. HBA Class II 1992-08-28
K922936 CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE Clinical Neuro Systems, LLC JXG Class II 1992-08-26
K922941 CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA Clinical Neuro Systems, LLC JXG Class II 1992-08-26
K921954 ISOTRON III Excel Tech. , Ltd. LIH Class II 1992-08-26
K921953 MULTI III Excel Tech. , Ltd. LIH Class II 1992-08-26
K921612 INTERTRON 4500, INTERTRON 5000, MASTERSTIM I-2 Medstar, Inc. LIH Class II 1992-08-18
K915530 NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE American Threshold Industries, Inc. HAX Class II 1992-08-17
K920352 BIO-DETEK EEG ELECTRODE Bio-Detek, Inc. GXZ Class II 1992-08-14
K921110 TENS Staodyne, Inc. GZJ Class II 1992-08-14
K923723 SILICONE BRAIN SPATULA SET Redmond Neurosurgical, Inc. HAO Class I 1992-08-12
K920324 ITC BUNJI COIL (MODIFICATION) Interventional Therapeutics Corp. HCG Class II 1992-07-29
K915791 CORITAXIC MULTI-MODAL STEREOTAXI WORKSTATION Coritechs, Inc. HAW Class II 1992-07-10
K921558 MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS Medtronic Vascular GZB Class II 1992-07-07
K904385 JANUS ATAC ENG ANALYSIS SYSTEM Life-Tech Intl., Inc. GWN Class II 1992-06-10
K920127 ELECTROENCEPHALOGRAPH RECORDING SYSTEM Medelec Intl. Corp. GWQ Class II 1992-06-10
K910447 DURA MATER Lifelink Foundation Tissue Bank LEM Class II 1992-06-09
K920264 BIO-DETEK TRACERITE EEG ELECTRODE Bio-Detek, Inc. GXY Class II 1992-06-02
K920567 MODELS 3987 AND 3988 RESUME LEAD FOR PNS Medtronic Vascular GZF Class II 1992-05-20
K903014 ALPHA-STIM CS Electromedical Products, Inc. QJQ Class II 1992-05-12
K910616 LB-2000 CRANIAL ELECTROTHERAPY STIMULATOR Life Balance Intl., Inc. QJQ Class II 1992-05-12
K915819 BRAINSCAN WORKSTATION Brainlab Medizinische Computersysteme GmbH HAW Class II 1992-05-11
K921441 INTERFERENTIAL STIMULATOR MODEL INF 4150/A Biomedical Life Systems, Inc. LIH Class II 1992-05-08
K915210 ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A Biomedical Life Systems, Inc. GZJ Class II 1992-05-04
K920088 CAMINO VENTRICULAR NEEDLE Camino Laboratories, Inc. HCD Class I 1992-05-01
K910555 TUTOPLAST DURA Pfrimmer-Viggo GmbH & Co. LEM Class II 1992-04-20
K913898 MYOTRAC+/S, MYODAC+/S Thought Technology , Ltd. HCC Class II 1992-03-26
K912139 MODEL 704 Ivy Biomedical Systems, Inc. GWM Class II 1992-03-25
K911911 MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM Medical Design & Manufacturing Corp. HCC Class II 1992-03-20
K920156 CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY Clinical Neuro Systems, LLC JXG Class II 1992-03-16
K915096 NEUROFAX EEG 5532 Nihon Kohden America, Inc. GWQ Class II 1992-03-11
K913765 YASARGIL ANEURYSM CLIPS, MODIFICATION Aesculap, Inc. HCH Class II 1992-03-11
K914995 CORDIS STRAIGHT VENTRICULAR CATHETER Cordis Corp. JXG Class II 1992-03-09
K912685 MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS Nihon Kohden America, Inc. GWF Class II 1992-02-26
K913842 CORDIS RIGHT-ANGLE CATHETER GUIDE Cordis Corp. JXG Class II 1992-02-19
K912643 ELECTRODE Skylark Device Co., Ltd. GXY Class II 1992-02-14
K913993 MEDTRONIC MODELS 3982 A,B,C&D STAG ARRAY RES LEADS Medtronic Vascular GZB Class II 1992-02-07
K911066 COMFORTRON PT (TENS) M. D. Supply, Inc. GZI Class II 1992-02-07
K915652 NICOLET PORATBLE SPIRIT SYSTEM Nicolet Instrument Corp. GWF Class II 1992-02-07
K912783 DISPOSABLE MONOPOLAR NEEDLE ELECTRODE Class A Ent. GXZ Class II 1992-02-05
K913957 DANTEC COUNTERPOINT MK2(TM) Dantec Medical, Inc. GWJ Class II 1992-01-30
K913031 K-STIM Katecho, Inc. GXY Class II 1992-01-30
K914571 NEUROTRAC II Moberg Medical, Inc. GWQ Class II 1992-01-30
K912381 LOW BACK STRIP (OR) K-BACK Katecho, Inc. GZJ Class II 1992-01-30
K913934 MEDTRONIC MODEL 3586 RESUME LEAD Medtronic Vascular GZB Class II 1992-01-22
K915540 MODEL 3587A RESUME II LEAD Medtronic Vascular GZF Class II 1992-01-22
K910624 CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 Wr Medical Electronics Co. LLN Class I 1992-01-17
K910727 EXCEL MODEL 2110 Excel Medical Systems, Inc. GZJ Class II 1992-01-17
K914735 VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM Camino Laboratories, Inc. GWM Class II 1992-01-17
K912760 AD-TECH EPIDURAL PEG ELECTRODE Ad-Tech Medical Instrument Corp GYC Class II 1992-01-15
K915333 ELECTRODE USING PROMEON RG-60 SERIES GEL Labeltape Meditect, Inc. GXY Class II 1992-01-14
K913490 PHOENIX BURR HOLE BUTTON, BURR 1 Phoenix Bioengineering, Inc. GXR Class II 1992-01-13
K914876 OPTI-AMP Intelligent Hearing Systems GWL Class II 1992-01-10
K913785 CORONET 100 Micro-Shev , Ltd. GWJ Class II 1991-12-31
K914813 THERASTIM Precision Electronics , Ltd. GZJ Class II 1991-12-31
K915546 PS MEDICAL VENTRICULOSTOMY KIT Pudenz-Schulte Medical Research Corp. HBG Class II 1991-12-30
K914433 MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS Medtronic Vascular GZB Class II 1991-12-23
K910771 DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX New England Medical Instruments, Inc. OMB Class II 1991-12-18
K914871 TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL Labeltape Meditect, Inc. GZJ Class II 1991-12-18
K914441 MENS 2000-D Monad Corp. GZJ Class II 1991-12-17
K913636 ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING Cordis Corp. JXG Class II 1991-12-12
K911963 MEDTRONIC MODEL 90002065 MF TENS SYSTEM Medtronic Vascular GZJ Class II 1991-12-10
K913604 SOMATOSENSORY STIMULUS SYSTEM Biomagnetic Technologies, Inc. GZP Class II 1991-12-09
K912764 MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT Medtronic Vascular GZB Class II 1991-11-22
K913442 MEDTRONIC 3625 SCREENER SYSTEM Medtronic Vascular GZB Class II 1991-11-22

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