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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
Recalls CDRH Recalls
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