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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 K133540
Device Name FLOCAP
Applicant
MAXTEC, INC.
6526 SOUTH COTTONWOOD ST.
SALT LAKE CITY,  UT  84107
Applicant Contact PAUL DRYDEN
Correspondent
MAXTEC, INC.
6526 SOUTH COTTONWOOD ST.
SALT LAKE CITY,  UT  84107
Correspondent Contact PAUL DRYDEN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received11/18/2013
Decision Date 03/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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