Acapella Choice Blue Vibratory PEP Device— 510(k) K181660
Substantially EquivalentSmiths Medical
FDA 510(k) clearance K181660 for Acapella Choice Blue Vibratory PEP Device, Substantially Equivalent on 2019-10-24. Applicant: Smiths Medical. Device class: 2.
Clearance details
- Applicant
- Smiths Medical
- 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
- Plymouth, MN, US
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