Conditioner, Signal, Physiological
Regulation 882.1845
0510(k)s in 12 months (23 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GWK
| Company | 510(k)s | Recalls |
|---|---|---|
| Respironics, Inc. | 3 | 0 |
| Bio-Logic Systems Corp. | 2 | 0 |
| Neurodiagnostics, Inc. | 2 | 0 |
| Nicolet Biomedical Instruments | 2 | 0 |
| Nihon Kohden America, Inc. | 2 | 0 |
| Astro-Med, Inc. | 1 | 0 |
| Axonics, Inc. | 1 | 0 |
| Bio-Feedback Systems, Inc. | 1 | 0 |
| Elmed, Inc. | 1 | 0 |
| Grass Instrument Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 22, 2006 | K060919 | ACTICAL Respironics, Inc. | GWK |
| Aug 31, 2006 | K061870 | VITALSENSE XHR Respironics, Inc. | GWK |
| Sep 27, 2005 | K052489 | ACTIHEART Respironics, Inc. | GWK |
| Sep 21, 1999 | K991045 | MINI-LOGGER SERIES 2000 Mini-Mitter Co., Inc. | GWK |
| Jun 28, 1991 | K905594 | NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 Nihon Kohden America, Inc. | GWK |
| Jun 18, 1991 | K904328 | VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM Telediagnostic Systems, Inc. | GWK |
| Jan 22, 1990 | K896164 | ASC-954 INTEGRATOR AMPLIFIER Astro-Med, Inc. | GWK |
| Oct 19, 1988 | K882599 | NICOLET BRAINLAB SYSTEM Nicolet Instrument Corp. | GWK |
| Oct 6, 1987 | K872290 | BIO-LOGIC BANKER Bio-Logic Systems Corp. | GWK |
| Mar 25, 1987 | K870381 | DD-VCR-64 Grass-Telefactor Product Group | GWK |
| Jun 6, 1986 | K860914 | ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV Bio-Feedback Systems, Inc. | GWK |
| Apr 11, 1985 | K843598 | BRAIN FUNCTION MAPPING OPTION FOR PATHF Nicolet Biomedical Instruments | GWK |
| Jun 7, 1984 | K841497 | NEUROPACK 8 MEE 4108 Nihon Kohden America, Inc. | GWK |
| Apr 30, 1984 | K841110 | NEUROTRAC Interspec, Inc. | GWK |
| Dec 1, 1983 | K833298 | AUDIT V AX 135 Axonics, Inc. | GWK |
| Feb 18, 1983 | K830191 | NEURO DIAGNOSTICS MODEL FCR Neurodiagnostics, Inc. | GWK |
| Feb 5, 1981 | K803226 | EVOKED RESPONSE STIMULATORS Bio-Logic Systems Corp. | GWK |
| Aug 4, 1980 | K801670 | NDI-IKE EMG Neurodiagnostics, Inc. | GWK |
| Aug 4, 1980 | K801604 | PATHFINDER ELECTRODIAGNOSTIC SYSTEM Nicolet Biomedical Instruments | GWK |
| Sep 15, 1978 | K781290 | SIGNAL AVERAGER MODEL 4202 Princeton Applied Research Corp. | GWK |
| Apr 19, 1978 | K780538 | AUDIO MONITOR-MODEL 8309 Life-Tech Instruments, Inc. | GWK |
| Nov 22, 1977 | K771742 | EVOKED RESPONSE SYS., MODEL 10 Grass Instrument Co. | GWK |
| May 6, 1977 | K770782 | FIBERSCOPIC SCOPE RECORDER SYSTEM Elmed, Inc. | GWK |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.