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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 K884822
Device Name MODEL OX-1 OXYGEN SATURATION MODULE
Applicant
COLIN MEDICAL INSTRUMENTS CORP.
107G CORPORATE BLVD.
SOUTH PLAINFIELD,  NJ  07080
Applicant Contact ALAN P SCHWARTZ
Correspondent
COLIN MEDICAL INSTRUMENTS CORP.
107G CORPORATE BLVD.
SOUTH PLAINFIELD,  NJ  07080
Correspondent Contact ALAN P SCHWARTZ
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/18/1988
Decision Date 03/02/1989
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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