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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 K883950
Device Name MODIFIED TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER
Applicant
FENEM, INC.
84 WILLIAM ST.
16TH FLOOR
NEW YORK,  NY  10038
Applicant Contact SHEILA A GLENNON
Correspondent
FENEM, INC.
84 WILLIAM ST.
16TH FLOOR
NEW YORK,  NY  10038
Correspondent Contact SHEILA A GLENNON
Regulation Number868.1400
Classification Product Code
CCK  
Date Received09/08/1988
Decision Date 09/29/1988
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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