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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 K172804
Device Name Besmed Peak Flow Meter
Applicant
Besmed Health Business Corp
#5, Lane 116, Wu-Kong 2nd Rd.
Wu-Ku District,  TW
Applicant Contact Lawrence Wu
Correspondent
Besmed Health Business Corp
#5, Lane 116, Wu-Kong 2nd Rd.
Wu-Ku District,  TW
Correspondent Contact Paul Dryden
Regulation Number868.1860
Classification Product Code
BZH  
Date Received09/18/2017
Decision Date 01/11/2018
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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