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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 Ave. Suite 1400
Austin,  TX  78701
Applicant Contact STUART R GOLDMAN
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. 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
Predetermined Change
Control Plan Authorized		 No
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