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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tracheal (w/wo connector)
510(k) Number K864161
Device Name TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER
Applicant
TOOB-CHEQ, INC.
11 MILLHOUSE LN.
CHERRY HILL,  NJ  08003
Applicant Contact FEHDER, M.D.
Correspondent
TOOB-CHEQ, INC.
11 MILLHOUSE LN.
CHERRY HILL,  NJ  08003
Correspondent Contact FEHDER, M.D.
Regulation Number868.5730
Classification Product Code
BTR  
Date Received10/23/1986
Decision Date 11/10/1986
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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