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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Peak Flow, Spirometry
510(k) Number K253180
Device Name Microlife Digital Peak Flow Meter, Model PF200B (PF200B)
Applicant
Microlife Corporation
9f, 431, Ruiguang Rd., Neihu
Taipei,  TW 11492
Applicant Contact Jimmy Deng
Correspondent
Mdi Consultants, Inc.
55 Northem Blvd., Suite 200
Greatneck,  NY  11021
Correspondent Contact Vaibhav Rajal
Regulation Number868.1860
Classification Product Code
BZH  
Date Received09/26/2025
Decision Date 06/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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