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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 K900673
Device Name SERIAL FLOW
Applicant
Spirometrics, Inc.
33 Omni Cir.
Auburn,  ME  04210
Applicant Contact ANN M THERRIAULT
Correspondent
Spirometrics, Inc.
33 Omni Cir.
Auburn,  ME  04210
Correspondent Contact ANN M THERRIAULT
Regulation Number868.1840
Classification Product Code
BZG  
Date Received02/13/1990
Decision Date 04/03/1990
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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