Combined Aerobika OPEP and VersaPAP device— 510(k) K183108
Substantially EquivalentTrudell Medical International
FDA 510(k) clearance K183108 for Combined Aerobika OPEP and VersaPAP device, Substantially Equivalent on 2019-08-16. Applicant: Trudell Medical International.
Clearance details
- Applicant
- Trudell Medical International
- Product code
- Code BWF
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- London, CA
Data sourced from openFDA. This site is unofficial and independent of the FDA.