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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K092219
Device Name NAVIGATOR CLINICAL GUIDENCE SYSTEM
Applicant
Applied Physiology Pty , Ltd.
13605 W. 7th Ave.
Golden,  CO  80401
Applicant Contact ROBERT N CLARK
Correspondent
Applied Physiology Pty , Ltd.
13605 W. 7th Ave.
Golden,  CO  80401
Correspondent Contact ROBERT N CLARK
Regulation Number870.1435
Classification Product Code
DXG  
Date Received07/22/2009
Decision Date 05/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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