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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 K921309
Device Name MODEL 508 PATIENT MONITOR
Applicant
CRITICARE SYSTEMS, INC.
P.O. BOX 26556
MILWAUKEE,  WI  53226
Applicant Contact ALEX KAPLAN
Correspondent
CRITICARE SYSTEMS, INC.
P.O. BOX 26556
MILWAUKEE,  WI  53226
Correspondent Contact ALEX KAPLAN
Regulation Number868.1890
Classification Product Code
BTY  
Date Received03/10/1992
Decision Date 12/17/1993
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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