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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 K901057
Device Name SPIROMETRICS MODEL 2600 MIRO SPIROMETER
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 Number868.1840
Classification Product Code
BZG  
Date Received03/06/1990
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
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