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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K102767
Device Name CARDIO XP
Applicant
BIONET CO., LTD.
5405 ALTON PARKWAY,
SUITE A530
IRVINE,  CA  92604
Applicant Contact MARC GOODMAN
Correspondent
BIONET CO., LTD.
5405 ALTON PARKWAY,
SUITE A530
IRVINE,  CA  92604
Correspondent Contact MARC GOODMAN
Regulation Number870.2340
Classification Product Code
DPS  
Date Received09/24/2010
Decision Date 06/03/2011
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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