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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K100913
Device Name IQVITALS AND IQVITALS SYSTEM
Applicant
Brentwood Medical Technology Corp.
3722 Ave., Sausalito
Irvine,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
Brentwood Medical Technology Corp.
3722 Ave., Sausalito
Irvine,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/01/2010
Decision Date 05/26/2010
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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