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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 K813352
Device Name NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN
Applicant
NOVAMETRIX MEDICAL SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
NOVAMETRIX MEDICAL SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2500
Classification Product Code
KLK  
Date Received11/27/1981
Decision Date 01/07/1982
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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