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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 K915059
Device Name PEAK FLOW MONITOR
Applicant
Spirometrics, Inc.
33 Omni Circle
Auburn,  ME  04210 -1210
Applicant Contact ANN M.THERRIAULT
Correspondent
Spirometrics, Inc.
33 Omni Circle
Auburn,  ME  04210 -1210
Correspondent Contact ANN M.THERRIAULT
Regulation Number868.1860
Classification Product Code
BZH  
Date Received11/08/1991
Decision Date 07/27/1992
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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