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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Carbon-Dioxide, Cutaneous
510(k) Number K890517
Device Name TRANSCUTANEOUS O2/CO2 MONITOR
Applicant
Novametrix Medical Systems, Inc.
1 Barnes Industrial Park Rd.
P.O. Box 690
Wallingford,  CT  06492
Applicant Contact ROBERT H SCHIFFMAN
Correspondent
Novametrix Medical Systems, Inc.
1 Barnes Industrial Park Rd.
P.O. Box 690
Wallingford,  CT  06492
Correspondent Contact ROBERT H SCHIFFMAN
Regulation Number868.2480
Classification Product Code
LKD  
Subsequent Product Code
KLK  
Date Received01/30/1989
Decision Date 04/14/1989
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
Recalls CDRH Recalls
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