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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 K914126
Device Name VMX MINI-LOG FLOWMETER
Applicant
Clement Clarke, Inc.
Airmed House, Edinburgh Way
Harlow, Essex Cm20 2ed
England,  GB
Applicant Contact MICHAEL J WILKINSON
Correspondent
Clement Clarke, Inc.
Airmed House, Edinburgh Way
Harlow, Essex Cm20 2ed
England,  GB
Correspondent Contact MICHAEL J WILKINSON
Regulation Number868.1860
Classification Product Code
BZH  
Date Received09/13/1991
Decision Date 03/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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