FDA 510(k), K142988, Sleepware G3

FDA 510(k), K142988, Sleepware G3

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510(K) Number: K142988
Device Name: Sleepware G3
Manufacturer: RESPIRONICS, INC.
Device Classification Name: automatic event detection software for polysomnograph with electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OLZ
Date Received: 10/16/2014
Decision Date: 03/16/2015
Regulation Medical Specialty: Neurology

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