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FDA 510(k), K202142, Sleepware G3
FDA 510(k), K202142, Sleepware G3
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510(K) Number: K202142
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: 07/31/2020
Decision Date: 10/29/2020
Regulation Medical Specialty: Neurology
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: 07/31/2020
Decision Date: 10/29/2020
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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