GWK · Conditioner, Signal, Physiological
Neurology · 21 CFR 882.1845 · Class 2
Overview
| Product Code | GWK |
|---|---|
| Device Name | Conditioner, Signal, Physiological |
| Regulation | 21 CFR 882.1845 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A physiological signal conditioner is a device such as an integrator or differentiator used to modify physiological signals for recording and processing.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K060919 | ACTICAL | Respironics, Inc. | Sep 22, 2006 | SESE |
| K061870 | VITALSENSE XHR | Respironics, Inc. | Aug 31, 2006 | SESE |
| K052489 | ACTIHEART | Respironics, Inc. | Sep 27, 2005 | SESE |
| K991045 | MINI-LOGGER SERIES 2000 | Mini-Mitter Co., Inc. | Sep 21, 1999 | SESE |
| K905594 | NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 | Nihon Kohden America, Inc. | Jun 28, 1991 | SESE |
| K904328 | VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM | Telediagnostic Systems, Inc. | Jun 18, 1991 | SESE |
| K896164 | ASC-954 INTEGRATOR AMPLIFIER | Astro-Med, Inc. | Jan 22, 1990 | SESE |
| K882599 | NICOLET BRAINLAB SYSTEM | Nicolet Instrument Corp. | Oct 19, 1988 | SESE |
| K872290 | BIO-LOGIC BANKER | Bio-Logic Systems Corp. | Oct 6, 1987 | SESE |
| K870381 | DD-VCR-64 | Grass-Telefactor Product Group | Mar 25, 1987 | SESE |
| K860914 | ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV | Bio-Feedback Systems, Inc. | Jun 6, 1986 | SESE |
| K843598 | BRAIN FUNCTION MAPPING OPTION FOR PATHF | Nicolet Biomedical Instruments | Apr 11, 1985 | SESE |
| K841497 | NEUROPACK 8 MEE 4108 | Nihon Kohden America, Inc. | Jun 7, 1984 | SESE |
| K841110 | NEUROTRAC | Interspec, Inc. | Apr 30, 1984 | SESE |
| K833298 | AUDIT V AX 135 | Axonics, Inc. | Dec 1, 1983 | SESE |
| K830191 | NEURO DIAGNOSTICS MODEL FCR | Neurodiagnostics, Inc. | Feb 18, 1983 | SESE |
| K803226 | EVOKED RESPONSE STIMULATORS | Bio-Logic Systems Corp. | Feb 5, 1981 | SESE |
| K801670 | NDI-IKE EMG | Neurodiagnostics, Inc. | Aug 4, 1980 | SESE |
| K801604 | PATHFINDER ELECTRODIAGNOSTIC SYSTEM | Nicolet Biomedical Instruments | Aug 4, 1980 | SESE |
| K781290 | SIGNAL AVERAGER MODEL 4202 | Princeton Applied Research Corp. | Sep 15, 1978 | SESE |
Top Applicants
- Respironics, Inc. — 3 clearances
- Bio-Logic Systems Corp. — 2 clearances
- Neurodiagnostics, Inc. — 2 clearances
- Nicolet Biomedical Instruments — 2 clearances
- Nihon Kohden America, Inc. — 2 clearances
