K253180
- 510(k) number
- K253180
- Device name
- Microlife Digital Peak Flow Meter, Model PF200B (PF200B)
- Applicant
- Microlife Corporation TW
- Product code
- BZH — Meter, Peak Flow, Spirometry
- Decision date
- 2026-06-23
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253180.pdf
Official FDA record: K253180
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.