510(k) K253180

Microlife Digital Peak Flow Meter, Model PF200B (PF200B) by Microlife Corporation — Product Code BZH

K253180 is an FDA 510(k) premarket notification submitted by Microlife Corporation for the device "Microlife Digital Peak Flow Meter, Model PF200B (PF200B)". The FDA issued a decision of Substantially Equivalent on June 23, 2026. The device falls under product code BZH (Meter, Peak Flow, Spirometry), a Class II device regulated under 21 CFR 868.1860. Microlife Corporation has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2026
Date Received
September 26, 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