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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, Oxygen, Gaseous-Phase
510(k) Number K040484
Device Name MAXO2+, MODEL A AND AE
Applicant
MAXTEC, INC.
6526 SOUTH COTTONWOOD ST.
SALT LAKE CITY,  UT  84107
Applicant Contact GORDON R ROTH
Correspondent
MAXTEC, INC.
6526 SOUTH COTTONWOOD ST.
SALT LAKE CITY,  UT  84107
Correspondent Contact GORDON R ROTH
Regulation Number868.1720
Classification Product Code
CCL  
Date Received02/25/2004
Decision Date 06/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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