Stimulator, Electrical, Evoked Response
Regulation 882.1870
3510(k)s in 12 months (141 all time)
2recalls in 12 months (17 all time)
17recalls that name a 510(k)
Top companies in GWF
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 20, 2005 | K051357 | DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH Digitimer , Ltd. | GWF |
| Aug 17, 2005 | K051178 | MEE-1000A NEUROMASTER Nihon Kohden America, Inc. | GWF |
| Aug 15, 2005 | K050798 | ECLIPSE NEUROLOGICAL WORKSTATION Axon Systems, Inc. | GWF |
| Jul 11, 2005 | K051384 | MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM Nuvasive, Inc. | GWF |
| Dec 29, 2004 | K030526 | PEDIGUARD NERVE DETECTOR SYSTEM Spine Vision, Inc. | GWF |
| Nov 3, 2004 | K042350 | TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR Cadwell Laboratories, Inc. | GWF |
| Aug 6, 2004 | K040358 | XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 Excel Tech. , Ltd., CA | GWF |
| Mar 3, 2004 | K031930 | HIGH SPEED EMG MODULE Medical Measurement Systems B.V., NL | GWF |
| Dec 16, 2003 | K032741 | EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION Axon Systems, Inc. | GWF |
| Aug 23, 2002 | K020400 | DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR Meps, LLC | GWF |
| Apr 2, 2001 | K010092 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED) Excel Tech. , Ltd., CA | GWF |
| Mar 26, 2001 | K010090 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED) Excel Tech. , Ltd., CA | GWF |
| Mar 19, 2001 | K010087 | XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP Excel Tech. , Ltd., CA | GWF |
| Dec 8, 2000 | K002969 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8 Xltek, CA | GWF |
| Oct 23, 2000 | K002773 | NEUROMAP WITH NEURO 100 Radionics, Inc. | GWF |
| Oct 20, 2000 | K000963 | DA VINCHI EEG AND EMG/EP SYSTEMS Airsep Corp. | GWF |
| Jun 30, 2000 | K001101 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4 Excel Tech. , Ltd., CA | GWF |
| Jan 7, 2000 | K992911 | MAGSTIM RAPID Magstim Corporation US | GWF |
| Sep 1, 1999 | K991899 | NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES Nihon Kohden America, Inc. | GWF |
| Aug 19, 1999 | K992313 | XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16 Excel Tech. , Ltd., CA | GWF |
| Jul 16, 1998 | K981405 | SYNERGY LT Oxford Instruments, Plc., GB | GWF |
| May 20, 1998 | K980866 | MEDI-DX 7000 CPT WITH AMREX ELECTRODES Neuro-Diagnostic Assoc. | GWF |
| Mar 16, 1998 | K971740 | AMPLAID MK12 Amplifon S.P.A. | GWF |
| Feb 6, 1998 | K972959 | AMPLAID MK22 Amplifon S.P.A. | GWF |
| Nov 20, 1997 | K971819 | EPOCH 2000 NEUROLOGICAL WORKSTATION Axon Systems, Inc. | GWF |
| Jun 20, 1997 | K965065 | TECA. MILLENNIUM Medelec , Ltd., GB | GWF |
| Feb 26, 1997 | K963662 | GALILEO EVOKED POTENTIALRE Biosound, Inc. | GWF |
| Jan 13, 1997 | K962458 | CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER Cadwell Laboratories, Inc. | GWF |
| Jan 13, 1997 | K962457 | TWO-CHANNEL PREAMPLIFIER Cadwell Laboratories, Inc. | GWF |
| Jan 13, 1997 | K962455 | FOUR-CHANNEL PREAMPLIFIER Cadwell Laboratories, Inc. | GWF |
| Apr 15, 1996 | K932994 | EVOKED POTENTIAL SYSTEM-1.0 Neuromedical Systems, Inc. | GWF |
| Mar 1, 1996 | K960170 | ELECTROENCEPHALOGRAPH (EEG) Moberg Medical, Inc. | GWF |
| Feb 2, 1996 | K955257 | SS102 DUAL CHANNEL SEP STIMULATOR Axon Systems, Inc. | GWF |
| Jan 26, 1996 | K952294 | NEURONET Computational Diagnostics, Inc. | GWF |
| Sep 19, 1995 | K944547 | DANTEC KEYPOINT Mckenna & Cuneo | GWF |
| May 10, 1995 | K950208 | NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM Nihon Kohden America, Inc. | GWF |
| Nov 9, 1993 | K931923 | DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE) Dantec Medical, Inc. | GWF |
| Aug 31, 1993 | K926516 | DANTEC MAGNETIC STIMULATOR MAGPRO Dantec Medical, Inc. | GWF |
| Jun 22, 1993 | K931428 | CADWELL 6200 A Cadwell Laboratories, Inc. | GWF |
| Mar 23, 1993 | K924723 | CADWELL SIERRA Cadwell Laboratories, Inc. | GWF |
| Mar 10, 1993 | K924127 | DANTEC EVOLUTION Dantec Medical, Inc. | GWF |
| Nov 24, 1992 | K923303 | SAPPHIRE PREMIERE Medelec , Ltd., GB | GWF |
| Nov 23, 1992 | K923315 | NICOLET ARK SYSTEM Nicolet Instrument Corp. | GWF |
| Feb 26, 1992 | K912685 | MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS Nihon Kohden America, Inc. | GWF |
| Feb 7, 1992 | K915652 | NICOLET PORATBLE SPIRIT SYSTEM Nicolet Instrument Corp. | GWF |
| Nov 8, 1991 | K912775 | SAPPHIRE 4ME EMG/EP SYSTEM Medelec Intl. Corp., GB | GWF |
| Sep 18, 1991 | K905059 | HIGH SPEED MAGNETIC STIMULATOR Cadwell Laboratories, Inc. | GWF |
| May 14, 1991 | K902607 | DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2) Dantec Medical, Inc. | GWF |
| Feb 4, 1991 | K903731 | SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME Teca, Inc. | GWF |
| Aug 8, 1990 | K894560 | QSI 9000 Quantified Signal Imaging, Inc., CA | GWF |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.