FDA Product Code
FDA Product Code GWK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1845
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K060919 | ACTICAL | Respironics, Inc. | 2006-09-22 | Traditional | PDF ↗ |
| K061870 | VITALSENSE XHR | Respironics, Inc. | 2006-08-31 | Special | PDF ↗ |
| K052489 | ACTIHEART | Respironics, Inc. | 2005-09-27 | Traditional | PDF ↗ |
| K991045 | MINI-LOGGER SERIES 2000 | Mini-Mitter Co., Inc. | 1999-09-21 | Traditional | PDF ↗ |
| K905594 | NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 | Nihon Kohden America, Inc. | 1991-06-28 | Traditional | PDF ↗ |
| K904328 | VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM | Telediagnostic Systems, Inc. | 1991-06-18 | Traditional | PDF ↗ |
| K896164 | ASC-954 INTEGRATOR AMPLIFIER | Astro-Med, Inc. | 1990-01-22 | Traditional | PDF ↗ |
| K882599 | NICOLET BRAINLAB SYSTEM | Nicolet Instrument Corp. | 1988-10-19 | Traditional | PDF ↗ |
| K872290 | BIO-LOGIC BANKER | Bio-Logic Systems Corp. | 1987-10-06 | Traditional | PDF ↗ |
| K870381 | DD-VCR-64 | Grass-Telefactor Product Group | 1987-03-25 | Traditional | PDF ↗ |
| K860914 | ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV | Bio-Feedback Systems, Inc. | 1986-06-06 | Traditional | PDF ↗ |
| K843598 | BRAIN FUNCTION MAPPING OPTION FOR PATHF | Nicolet Biomedical Instruments | 1985-04-11 | Traditional | PDF ↗ |
| K841497 | NEUROPACK 8 MEE 4108 | Nihon Kohden America, Inc. | 1984-06-07 | Traditional | PDF ↗ |
| K841110 | NEUROTRAC | Interspec, Inc. | 1984-04-30 | Traditional | PDF ↗ |
| K833298 | AUDIT V AX 135 | Axonics, Inc. | 1983-12-01 | Traditional | PDF ↗ |
| K830191 | NEURO DIAGNOSTICS MODEL FCR | Neurodiagnostics, Inc. | 1983-02-18 | Traditional | PDF ↗ |
| K803226 | EVOKED RESPONSE STIMULATORS | Bio-Logic Systems Corp. | 1981-02-05 | Traditional | PDF ↗ |
| K801604 | PATHFINDER ELECTRODIAGNOSTIC SYSTEM | Nicolet Biomedical Instruments | 1980-08-04 | Traditional | PDF ↗ |
| K801670 | NDI-IKE EMG | Neurodiagnostics, Inc. | 1980-08-04 | Traditional | PDF ↗ |
| K781290 | SIGNAL AVERAGER MODEL 4202 | Princeton Applied Research Corp. | 1978-09-15 | Traditional | PDF ↗ |
| K780538 | AUDIO MONITOR-MODEL 8309 | Life-Tech Instruments, Inc. | 1978-04-19 | Traditional | PDF ↗ |
| K771742 | EVOKED RESPONSE SYS., MODEL 10 | Grass Instrument Co. | 1977-11-22 | Traditional | PDF ↗ |
| K770782 | FIBERSCOPIC SCOPE RECORDER SYSTEM | Elmed, Inc. | 1977-05-06 | Traditional | PDF ↗ |
Product code GWK · Class II · Neurology. Data: openFDA.