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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K910019
Device Name NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON
Applicant
NOVAMETRIX MEDICAL SYSTEMS, INC.
1 BARNES INDUSTRIAL PARK RD.
P.O. BOX 690
WALLINGFORD,  CT  06492
Applicant Contact ROBERT SCHIFFMAN
Correspondent
NOVAMETRIX MEDICAL SYSTEMS, INC.
1 BARNES INDUSTRIAL PARK RD.
P.O. BOX 690
WALLINGFORD,  CT  06492
Correspondent Contact ROBERT SCHIFFMAN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received01/03/1991
Decision Date 03/26/1991
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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