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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 K844333
Device Name SPIROMETRICS 2451 & SMI I
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 Number868.1840
Classification Product Code
BZG  
Date Received11/07/1984
Decision Date 11/20/1984
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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