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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 K941226
Device Name AIRWATCH MONITOR
Applicant
Enact Health Management Systems
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact DIANE E MINEAR
Correspondent
Enact Health Management Systems
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact DIANE E MINEAR
Regulation Number868.1860
Classification Product Code
BZH  
Date Received03/14/1994
Decision Date 11/16/1994
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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