meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
31
Latest Decision
1984-12-24

Clearances · page 57 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K843486 VIBRAMETER Somedic AB LLN Class I 1984-12-24
K844015 CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE Cns, Inc. GWS Class I 1984-12-17
K842886 TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL Teca, Inc. GWN Class II 1984-12-12
K844097 CANMED 103 9300 ELECTRODE Medtronic Vascular GXY Class II 1984-12-11
K844646 SIEGEN SURFACE ELECTRODES Siegen Corp. GXY Class II 1984-12-11
K843738 CAB2 COMPUTER ASSISTED BIOFEEDBACK Discrete Data Systems, Inc. HCC Class II 1984-12-04
K841653 DEL MAR AVIONICS 5509 NEURO-SCANNER Del Mar Avionics GWQ Class II 1984-12-03
K843923 THYMATRON Somatics, Inc. QGH Class II 1984-12-03
K842543 EVOKED POTENTIAL SYS Bio-Logic Systems Corp. GWF Class II 1984-11-29
K843637 HEALTH PULSE FA-222 TRANSCUTANEOUS ELEC. NERVE STI Therapeutic Equipment Corp. GZJ Class II 1984-11-29
K840099 MODEL 800-A VERI/PPR Verite GZJ Class II 1984-11-28
K843413 STRESS CONTROL BIOFEEDBACK CARD Pilgrim Plastic Products Co. HCC Class II 1984-11-27
K843253 EMG/NCV & EVOKED RESPONSE, DESIGN W/ Neurodiagnostics, Inc. GWF Class II 1984-11-20
K843464 SIEGEN NEUROSCOPE Siegen Corp. GWF Class II 1984-11-20
K842381 SLS 3500 LED VISUAL STIMULATOR Nihon Kohden America, Inc. GWE Class II 1984-11-09
K843808 DUAL CHENNEL BRAIN ACTIVITY MONITOR Datex Division Instrumentarium Corp. OLT Class II 1984-11-08
K843004 SERVO MED NYSTAGMOGRAPH NG-1 Servo Med, Inc. GWN Class II 1984-10-30
K843822 MEA110 Canadian Medical Products GZJ Class II 1984-10-22
K843793 A-T TENS BELT A-T Surgical Mfg. Co., Inc. GZJ Class II 1984-10-12
K841184 ELECTRO-NERVE STIMULATOR HL Biomedical Life Systems, Inc. GZJ Class II 1984-10-04
K842714 EEG-4300 W/OPTINAL ACCESS. EEG 4314 & Nihon Kohden America, Inc. GWQ Class II 1984-09-25
K843132 RADIONICS MINI & STANDARD SHUNT VALVE Radionics, Inc. JXG Class II 1984-09-12
K842788 DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE Brimms, Inc. JXL Class II 1984-09-11
K842680 ACE UNIVERSAL TONG Buckman Co., Inc. HAX Class II 1984-09-04
K843119 ETI TENS BELT Electro Therapeutic Devices, Inc. GZJ Class II 1984-08-17
K834442 LED STIMULATOR LS-05 Teca, Inc. GWE Class II 1984-08-08
K842812 MENTOR 150 PLUS TRANSCUTANEOUS ELEC. Mentor Corp. GZJ Class II 1984-08-08
K842414 ECHO PULSE BURST Rabar, Inc. GZJ Class II 1984-07-27
K842033 ELECTRODE PLACEMENT ARM PART GARMENT Bio-Stimu Trend Corp. GXY Class II 1984-07-26
K842023 TEMP. & GSR BIOFEEDBACK DEVICE Electronics Research & Production HCC Class II 1984-07-20
K842022 EEG BIOFEEDBACK DEVICE Electronics Research & Production HCC Class II 1984-07-20
K842271 ELECTRODE, SURFACE EEG ELECTRODE Durden Enterprises, Inc. GXY Class II 1984-07-20
K842021 EEG BIOFEEDBACK DEVICE ACCESSORY Electronics Research & Production HCC Class II 1984-07-20
K841877 EEG ELECTRODE PAD Neurologics, Inc. GXY Class II 1984-07-19
K842354 EMG MODEL 133 Calnor of EL Paseo, Inc. HCC Class II 1984-07-17
K841895 GSR, 126, EEG 130-TEMP. 132, EMG 133 Calnor of EL Paseo, Inc. HCC Class II 1984-07-17
K842288 EEG 130 Calnor of EL Paseo, Inc. HCC Class II 1984-07-17
K840098 MODEL 811 VERI/TENS & PO Verite GZJ Class II 1984-07-17
K842353 TEMPERATURE 132 Calnor of EL Paseo, Inc. HCC Class II 1984-07-17
K842108 UNIVERSAL EXAMINATION TABLE Engineering Dynamics Corp. GZO Class II 1984-07-17
K841128 RELAX STRESS REDUCTION SYS Synapse Software Corp. HCC Class II 1984-07-16
K841790 LIFESCAN EEG MONITOR Neurometrics OLT Class II 1984-07-12
K841400 NEURO PULSE Parker Laboratories, Inc. GZJ Class II 1984-06-15
K841612 NEUROPACK II 5100 Nihon Kohden America, Inc. GWL Class II 1984-06-07
K841684 BIO/SCAN BIOLOG CASSETTE RECORDER Bio-Scan, Inc. GWQ Class II 1984-06-07
K841497 NEUROPACK 8 MEE 4108 Nihon Kohden America, Inc. GWK Class II 1984-06-07
K841685 EEG ELECTRODES Bio-Scan, Inc. GXY Class II 1984-06-07
K841683 Q.P. PREAMPLIFIER SYS Bio-Scan, Inc. GWQ Class II 1984-06-07
K833522 NEURO SECTOR FIXATION DEVICE Advanced Technology Laboratories, Inc. GXW Class II 1984-05-25
K833822 P-S MEDICAL CSF ACCESS DEV 15MM/25MM Pudenz-Schulte Medical Research Corp. LKG Class II 1984-05-25
K841553 H-H SHUNT PASSERS Holter-Hausner Intl. GYK Class I 1984-05-14
K841584 MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL Medtronic Vascular GZB Class II 1984-05-14
K841110 NEUROTRAC Interspec, Inc. GWK Class II 1984-04-30
K840396 ELECTRO-MESH WRAP Whiting & Davis Co. GXY Class II 1984-04-30
K840395 ELECTRO-MESH GLOVE Whiting & Davis Co. GXY Class II 1984-04-30
K840964 SD PLUS CLINICIAN CAT# 78-8015 Codman & Shurtleff, Inc. GZJ Class II 1984-04-23
K840963 SD PLUS PATIENT CAT.#78-8010 Codman & Shurtleff, Inc. GZJ Class II 1984-04-23
K841442 P-S MEDICAL CSF-FLOW CONTROL VALVE- P-S Medical JXG Class II 1984-04-19
K840497 OBSTETRIC PULSAR TWO CHANNEL TENS Spembly Medical , Ltd. GZJ Class II 1984-04-16
K841045 EMPI MODEL 984 BASIX, TENS Empi GZJ Class II 1984-04-13
K841000 BET MODEL 1010 Bioelectro Technologies GZJ Class II 1984-04-13
K840599 MULTI-STIMT Joanco Medical Electronics , Ltd. GZJ Class II 1984-04-13
K840789 BITESTICK BLOCK Cherry Plastics, Inc. JXL Class II 1984-04-05
K840821 TRNS MI 8202 Medical Scientific Instruments GZJ Class II 1984-04-05
K840999 PHILLY INFANT BOLT Philadelphia Medical Specialties GWM Class II 1984-04-04
K834593 ONE-PIECE SHUNT American Heyer Schulte JXG Class II 1984-04-03
K840592 ELECTRODE PLACEMENT LUMBAR SHORTS Bio-Stimu Trend Corp. GXY Class II 1984-03-23
K840591 ELECTRODE PLACEMENT SLEEVE Bio-Stimu Trend Corp. GXY Class II 1984-03-23
K834477 DISPOS. SCOTT CANNULAS 16-1054 ETC. Codman & Shurtleff, Inc. HCA Class II 1984-03-19
K833990 SPINAL CORD STIMULATION SYS SE-4 Medtronic Vascular GZB Class II 1984-03-19
K840321 ENDODYNE DUAL Elmed, Inc. LIH Class II 1984-03-16
K840487 T-METER K.J. Electronics HCS Class II 1984-03-12
K840223 ORION BIOFEEDBACK DATA ACQUISITION Self Regulation Systems, Inc. HCC Class II 1984-03-09
K833672 HH SUBCUTANEOUS ACCESS PORT Holter-Hausner Intl. LKG Class II 1984-03-06
K833251 MODEL MK II TENS European Electronic Systems, Ltd. GZJ Class II 1984-03-05
K840003 DISPOSABLE ICP KIT DIFF. SIZES Codman & Shurtleff, Inc. GWM Class II 1984-02-28
K840314 CAT 10-NEUROLOGY DEVICE Imm Enterprises , Ltd. GWZ Class I 1984-02-23
K834170 OP-CON SURG. INSTRUMENT #10 Imm Enterprises , Ltd. GWZ Class I 1984-02-23
K834178 H.R. JAKOBI SURG. INSTR. #10 34/36 Imm Enterprises , Ltd. GWZ Class I 1984-02-23
K834047 PMT-HALO/ORTHOPEDIC JACKET SYSTEM Progress Mankind Technology HAX Class II 1984-02-17
K834334 MEDAID DUAL CHANNEL TENS Par Medex , Ltd. GZJ Class II 1984-02-13
K834148 PHILLY BOLTS Philadelphia Medical Specialties GWN Class II 1984-02-10
K840040 HEALTH-UP Kung-Ho International, Inc. GZJ Class II 1984-02-10
K834110 ANTENSE ANTI-TENSION DEVICE Bio Sig Instruments, Inc. HCC Class II 1984-02-04
K834111 ANTACHE ANTI-HEADACHE DEVICE Bio Sig Instruments, Inc. HCC Class II 1984-02-03
K834519 CALMTONE Thought Technology , Ltd. HCC Class II 1984-01-30
K833652 YASARGIL FENESTRATED ANEURYSM CLIP & Advanced Biosearch Assn. HCH Class II 1984-01-27
K833086 NEUROTRON 100 Neutro-Tronics GZJ Class II 1984-01-24
K833650 YASARGIL STANDARD ANEURYSM CLIP & Advanced Biosearch Assn. HCH Class II 1984-01-18
K834215 MINI-1 TRANSCUTANEOUS ELEC-NERVE STIM Th Charters, Inc. GZJ Class II 1984-01-03
K833484 COMPUTED TOMOGRAPHY ORIENTED ROTARY ARC A. Patil, M.D. HAW Class II 1983-12-29
K833266 ACRA-CUT Acra Cut, Inc. HBF Class II 1983-12-29
K831938 TRANSCUTANEOUS ELECTRONIC NERVE STIMU Joseph M. Piocentile GZJ Class II 1983-12-22
K833809 NEURAL STIMULATOR MONITOR Instromedix, Inc. GZB Class II 1983-12-01
K833298 AUDIT V AX 135 Axonics, Inc. GWK Class II 1983-12-01
K833651 CLIP APPLYING FORCEPS Advanced Biosearch Assn. HCI Class II 1983-11-29
K833236 TELEPHONE TRANSMITTER T-10 EEG Pharmaquest Corp. GYE Class II 1983-11-29
K833037 POINTER F-3 Petra Intl. Co. GZJ Class II 1983-11-29
K833880 TELEPHONIC RECEIVER R-10 EEG Pharmaquest Corp. GYE Class II 1983-11-29
K831990 NEUROFLAX, EPK Franks Electronics GZJ Class II 1983-11-28

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