Sleepware G3— 510(k) K142988
Substantially EquivalentRespironics, Inc.
FDA 510(k) clearance K142988 for Sleepware G3, Substantially Equivalent on 2015-03-16. Applicant: Respironics, Inc.. Device class: 2.
Clearance details
- Applicant
- Respironics, Inc.
- Product code
- Code OLZ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murrysville, PA, US
Recent devices under product code OLZ
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