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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 K063488
Device Name MAXO2 CU
Applicant
Maxtec, Inc.
3460 Pointe Creek Ct. # 102
Bonita Springs,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
Maxtec, Inc.
3460 Pointe Creek Ct. # 102
Bonita Springs,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number868.1720
Classification Product Code
CCL  
Date Received11/17/2006
Decision Date 02/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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