APNEALINK PLUS, MODEL: 22328— 510(k) K083575
Substantially EquivalentResmed Germany, Inc.
FDA 510(k) clearance K083575 for APNEALINK PLUS, MODEL: 22328, Substantially Equivalent on 2009-03-19. Applicant: Resmed Germany, Inc.. Device class: 2.
Clearance details
- Applicant
- Resmed Germany, Inc.
- Product code
- Code MNR
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Poway, CA, US
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