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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 K953411
Device Name BREATH-TAKER BREATH-ALERT
Applicant
Roxon - Universal Medical , Ltd.
141, E. - Columbia St.
New Westminister, B.C.,  CA V3L 3V9
Applicant Contact MO SHARIFF
Correspondent
Roxon - Universal Medical , Ltd.
141, E. - Columbia St.
New Westminister, B.C.,  CA V3L 3V9
Correspondent Contact MO SHARIFF
Regulation Number868.1860
Classification Product Code
BZH  
Date Received07/20/1995
Decision Date 06/13/1996
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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