Microlife Digital Peak Flow Meter, Model PF200B (PF200B)— 510(k) K253180
Substantially EquivalentMicrolife Corporation
FDA 510(k) clearance K253180 for Microlife Digital Peak Flow Meter, Model PF200B (PF200B), Substantially Equivalent on 2026-06-23. Applicant: Microlife Corporation. Device class: 2.
Summary
Microlife's Digital Peak Flow Meter, Model PF200B, is filed under BZH, spirometry peak flow meters. The record doesn't describe it beyond the model number and the code name.
Class II, 21 CFR 868.1860. Anesthesiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Microlife filed from Taipei, Taiwan. The decision came 270 calendar days after receipt (September 26, 2025 to June 23, 2026).
Clearance details
- Applicant
- Microlife Corporation
- Product code
- Product code BZH
- Device class
- Class 2
- Regulation
- 21 CFR 868.1860
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taipei, TW
Recent devices under product code BZH
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