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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calculator, predicted values, pulmonary function
510(k) Number K850045
Device Name SPIROMETRICS 2453 & SMI III
Applicant
SPIROMETRICS, INC.
26 ESSEX ST.
ANDOVER,  MA  01810
Applicant Contact NOEL G WRAY
Correspondent
SPIROMETRICS, INC.
26 ESSEX ST.
ANDOVER,  MA  01810
Correspondent Contact NOEL G WRAY
Regulation Number868.1890
Classification Product Code
BTY  
Date Received01/07/1985
Decision Date 02/14/1985
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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