510(k) K252802
K252802 is an FDA 510(k) premarket notification submitted by Shenzhen Bi-Rich Medical Devices Co., Ltd. for the device "Peak Flow Meter (PF-10(BR-PEF231))". The FDA issued a decision of Substantially Equivalent on May 29, 2026. The device falls under product code BZH (Meter, Peak Flow, Spirometry), a Class II device regulated under 21 CFR 868.1860.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 2026
- Date Received
- September 3, 2025
- 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