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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 K844079
Device Name NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN
Applicant
NOVAMETRIX MEDICAL SYSTEMS, INC.
1 BARNES INDUSTRIAL PARK RD.
P.O. BOX 690
WALLINGFORD,  CT  06492
Applicant Contact PAUL V BUDDAY
Correspondent
NOVAMETRIX MEDICAL SYSTEMS, INC.
1 BARNES INDUSTRIAL PARK RD.
P.O. BOX 690
WALLINGFORD,  CT  06492
Correspondent Contact PAUL V BUDDAY
Regulation Number868.2500
Classification Product Code
KLK  
Date Received10/19/1984
Decision Date 11/30/1984
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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