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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 K053407
Device Name OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M
Applicant
Analytical Industries, Inc.
2855 Metropolitan Pl.
Pomona,  CA  91767
Applicant Contact PATRICK J PRINDIBLE
Correspondent
Analytical Industries, Inc.
2855 Metropolitan Pl.
Pomona,  CA  91767
Correspondent Contact PATRICK J PRINDIBLE
Regulation Number868.1720
Classification Product Code
CCL  
Date Received12/07/2005
Decision Date 04/05/2006
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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