510(k) K172804
K172804 is an FDA 510(k) premarket notification submitted by Besmed Health Business Corp for the device "Besmed Peak Flow Meter". The FDA issued a decision of Substantially Equivalent on January 11, 2018. The device falls under product code BZH (Meter, Peak Flow, Spirometry), a Class II device regulated under 21 CFR 868.1860. Besmed Health Business Corp has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 2018
- Date Received
- September 18, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Meter, Peak Flow, Spirometry
- Device Class
- Class II
- Regulation Number
- 868.1860
- Review Panel
- AN
- Submission Type