GWK — Conditioner, Signal, Physiological Class II
FDA product code GWK covers "Conditioner, Signal, Physiological", a Class II medical device regulated under 21 CFR 882.1845. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GWK
- Device Class
- Class II
- Regulation Number
- 882.1845
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K060919 | respironics | ACTICAL | September 22, 2006 |
| K061870 | respironics | VITALSENSE XHR | August 31, 2006 |
| K052489 | respironics | ACTIHEART | September 27, 2005 |
| K991045 | mini-mitter co | MINI-LOGGER SERIES 2000 | September 21, 1999 |
| K905594 | nihon kohden america | NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 | June 28, 1991 |
| K904328 | telediagnostic systems | VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM | June 18, 1991 |
| K896164 | astro-med | ASC-954 INTEGRATOR AMPLIFIER | January 22, 1990 |
| K882599 | nicolet instrument | NICOLET BRAINLAB SYSTEM | October 19, 1988 |
| K872290 | bio-logic systems | BIO-LOGIC BANKER | October 6, 1987 |
| K870381 | grass-telefactor product group | DD-VCR-64 | March 25, 1987 |
| K860914 | bio-feedback systems | ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV | June 6, 1986 |
| K843598 | nicolet biomedical instruments | BRAIN FUNCTION MAPPING OPTION FOR PATHF | April 11, 1985 |
| K841497 | nihon kohden america | NEUROPACK 8 MEE 4108 | June 7, 1984 |
| K841110 | interspec | NEUROTRAC | April 30, 1984 |
| K833298 | axonics | AUDIT V AX 135 | December 1, 1983 |
| K830191 | neurodiagnostics | NEURO DIAGNOSTICS MODEL FCR | February 18, 1983 |
| K803226 | bio-logic systems | EVOKED RESPONSE STIMULATORS | February 5, 1981 |
| K801670 | neurodiagnostics | NDI-IKE EMG | August 4, 1980 |
| K801604 | nicolet biomedical instruments | PATHFINDER ELECTRODIAGNOSTIC SYSTEM | August 4, 1980 |
| K781290 | princeton applied research | SIGNAL AVERAGER MODEL 4202 | September 15, 1978 |