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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K895953
Device Name WRIGHT VENTILOMETER VM-1
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 Number868.1840
Classification Product Code
BZG  
Date Received10/11/1989
Decision Date 02/02/1990
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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