510(k) K133873
K133873 is an FDA 510(k) premarket notification submitted by Besmed Health Business Corp for the device "TRIBALL INCENTIVE SPIROMETER". The FDA issued a decision of Substantially Equivalent on April 4, 2014. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Besmed Health Business Corp has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2014
- Date Received
- December 20, 2013
- 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