Conditioner, Signal, Physiological
FDA product code GWK · Class II (moderate risk) · 21 CFR 882.1845 · Neurology
23510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Respironics, Inc. 3
- Nicolet Biomedical Instruments 2
- Neurodiagnostics, Inc. 2
- Bio-Logic Systems Corp. 2
- Nihon Kohden America, Inc. 2
- Interspec, Inc. 1
- Mini-Mitter Co., Inc. 1
- Telediagnostic Systems, Inc. 1
- Astro-Med, Inc. 1
- Nicolet Instrument Corp. 1
- Grass-Telefactor Product Group 1
- Bio-Feedback Systems, Inc. 1
- Elmed, Inc. 1
- Axonics, Inc. 1
- Princeton Applied Research Corp. 1
- Life-Tech Instruments, Inc. 1
- Grass Instrument Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K060919 | ActicalGWK · Traditional | Respironics, Inc. | 09/22/2006SE |
| K061870 | Vitalsense XHRGWK · Special | Respironics, Inc. | 08/31/2006SE |
| K052489 | ActiheartGWK · Traditional | Respironics, Inc. | 09/27/2005SE |
| K991045 | Mini-Logger Series 2000GWK · Traditional | Mini-Mitter Co., Inc. | 09/21/1999SE |
| K905594 | Neurofile Data Storage/Accesories to the EEG-4300GWK · Traditional | Nihon Kohden America, Inc. | 06/28/1991SE |
| K904328 | Vista Polysomnography Computer SystemGWK · Traditional | Telediagnostic Systems, Inc. | 06/18/1991SE |
| K896164 | ASC-954 Integrator AmplifierGWK · Traditional | Astro-Med, Inc. | 01/22/1990SE |
| K882599 | Nicolet Brainlab SystemGWK · Traditional | Nicolet Instrument Corp. | 10/19/1988SE |
| K872290 | Bio-Logic BankerGWK · Traditional | Bio-Logic Systems Corp. | 10/06/1987SE |
| K870381 | DD-VCR-64GWK · Traditional | Grass-Telefactor Product Group | 03/25/1987SE |
| K860914 | Isolated Solid-State Relay Multiplexer & F/F ConvGWK · Traditional | Bio-Feedback Systems, Inc. | 06/06/1986SE |
| K843598 | Brain Function Mapping Option for PathfGWK · Traditional | Nicolet Biomedical Instruments | 04/11/1985SE |
| K841497 | Neuropack 8 Mee 4108GWK · Traditional | Nihon Kohden America, Inc. | 06/07/1984SE |
| K841110 | NeurotracGWK · Traditional | Interspec, Inc. | 04/30/1984SE |
| K833298 | Audit V Ax 135GWK · Traditional | Axonics, Inc. | 12/01/1983SE |
| K830191 | Neuro Diagnostics Model FCRGWK · Traditional | Neurodiagnostics, Inc. | 02/18/1983SE |
| K803226 | Evoked Response StimulatorsGWK · Traditional | Bio-Logic Systems Corp. | 02/05/1981SE |
| K801670 | Ndi-Ike EmgGWK · Traditional | Neurodiagnostics, Inc. | 08/04/1980SE |
| K801604 | Pathfinder Electrodiagnostic SystemGWK · Traditional | Nicolet Biomedical Instruments | 08/04/1980SE |
| K781290 | Signal Averager Model 4202GWK · Traditional | Princeton Applied Research Corp. | 09/15/1978SE |
| K780538 | Audio Monitor-Model 8309GWK · Traditional | Life-Tech Instruments, Inc. | 04/19/1978SE |
| K771742 | Evoked Response Sys., Model 10GWK · Traditional | Grass Instrument Co. | 11/22/1977SE |
| K770782 | Fiberscopic Scope Recorder SystemGWK · Traditional | Elmed, Inc. | 05/06/1977SE |