GWKClass II
Conditioner, Signal, Physiological
Neurology · 21 CFR 882.1845
MDR events1All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances23All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Unspecified1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
23 clearances for this product code
- Respironics, Inc.Sep 22, 2006
K060919 · ACTICAL
- Respironics, Inc.Aug 31, 2006
K061870 · VITALSENSE XHR
- Respironics, Inc.Sep 27, 2005
K052489 · ACTIHEART
- Mini-Mitter Co., Inc.Sep 21, 1999
K991045 · MINI-LOGGER SERIES 2000
- Nihon Kohden America, Inc.Jun 28, 1991
K905594 · NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300
- Telediagnostic Systems, Inc.Jun 18, 1991
K904328 · VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM
- Astro-Med, Inc.Jan 22, 1990
K896164 · ASC-954 INTEGRATOR AMPLIFIER
- Nicolet Instrument Corp.Oct 19, 1988
K882599 · NICOLET BRAINLAB SYSTEM