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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 K822328
Device Name IL 301 TRANSCUTANEOUS OXYGEN MONITOR
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 Received08/03/1982
Decision Date 09/07/1982
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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