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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 K842374
Device Name NOVAMETRIX 850 TRANSCUTANEOUS 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 Received06/18/1984
Decision Date 09/17/1984
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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