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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 K952713
Device Name MINI WRIGHT LR AFS
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 Received06/14/1995
Decision Date 03/29/1996
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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