VersaPAP Positive Airway Pressure (PAP) Device— 510(k) K173918
Substantially EquivalentTrudell Medical International
FDA 510(k) clearance K173918 for VersaPAP Positive Airway Pressure (PAP) Device, Substantially Equivalent on 2018-08-17. Applicant: Trudell Medical International. Device class: 2.
Clearance details
- Applicant
- Trudell Medical International
- Product code
- Code BWF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5690
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- London, CA
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