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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 K844253
Device Name NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2
Applicant
Novametrix Medical Systems, Inc.
1 Barnes Industrial Park Rd.
P.O. Box 690
Wallingford,  CT  06492
Applicant Contact PAUL V BUDAY
Correspondent
Novametrix Medical Systems, Inc.
1 Barnes Industrial Park Rd.
P.O. Box 690
Wallingford,  CT  06492
Correspondent Contact PAUL V BUDAY
Regulation Number868.2500
Classification Product Code
KLK  
Date Received11/02/1984
Decision Date 01/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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