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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 K042273
Device Name MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY
Applicant
Health Hero Network, Inc.
2570 W. El Camino Real
Suite 111
Mountain View,  CA  94040 -1309
Applicant Contact GEOFFREY J CLAPP
Correspondent
Health Hero Network, Inc.
2570 W. El Camino Real
Suite 111
Mountain View,  CA  94040 -1309
Correspondent Contact GEOFFREY J CLAPP
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/23/2004
Decision Date 08/31/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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