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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 K874947
Device Name MODEL 8800 CARDIORESPIRATORY OXIMETER
Applicant
NONIN MEDICAL, INC.
13030 HIGHWAY 55
PLYMOUTH,  MA  55441
Applicant Contact NEAL F NORDLING
Correspondent
NONIN MEDICAL, INC.
13030 HIGHWAY 55
PLYMOUTH,  MA  55441
Correspondent Contact NEAL F NORDLING
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/02/1987
Decision Date 02/12/1988
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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