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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K910770
Device Name 504US PULSE OXIMETER
Applicant
CRITICARE SYSTEMS, INC.
P.O. BOX 26556
MILWAUKEE,  WI  53226
Applicant Contact DER RUHR
Correspondent
CRITICARE SYSTEMS, INC.
P.O. BOX 26556
MILWAUKEE,  WI  53226
Correspondent Contact DER RUHR
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/22/1991
Decision Date 05/14/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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