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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 K882664
Device Name MRL OXIMETER
Applicant
MEDICAL RESEARCH LABORATORIES, INC.
6457 W. HOWARD ST.
NILES,  IL  60648
Applicant Contact DILIP MEHTA
Correspondent
MEDICAL RESEARCH LABORATORIES, INC.
6457 W. HOWARD ST.
NILES,  IL  60648
Correspondent Contact DILIP MEHTA
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/27/1988
Decision Date 09/16/1988
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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