510(k) K153441
K153441 is an FDA 510(k) premarket notification submitted by Medica Holdings, LLC for the device "VibraPEP". The FDA issued a decision of Substantially Equivalent on March 25, 2016. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Medica Holdings, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 2016
- Date Received
- November 27, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spirometer, Therapeutic (Incentive)
- Device Class
- Class II
- Regulation Number
- 868.5690
- Review Panel
- AN
- Submission Type