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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 K133806
Device Name M1 CAPNOGRAPHY MASK
Applicant
MONITOR MASK, INC.
816 CONGRESS AVENUE, SUITE 1400
AUSTIN,  TX  78701
Applicant Contact STUART R GOLDMAN
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Code
BYG  
Date Received12/16/2013
Decision Date 12/31/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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