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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
510(k) Number K834057
Device Name IL 301 PORTABLE TRANSCUT. OXYGEN MONI
Applicant
INSTRUMENTATION LABORATORY CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
INSTRUMENTATION LABORATORY CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2500
Classification Product Code
KLK  
Date Received11/23/1983
Decision Date 02/04/1984
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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