AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE— 510(k) K123400
Substantially EquivalentTrudell Medical Intl.
FDA 510(k) clearance K123400 for AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE, Substantially Equivalent on 2013-05-16. Applicant: Trudell Medical Intl.. Device class: 2.
Clearance details
- Applicant
- Trudell Medical Intl.
- 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
Recent devices under product code BWF
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