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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K080091
Device Name MODIFICATION TO:HEALTH BUDDY APPLIANCE
Applicant
Health Hero Network, Inc.
2400 Geng Rd. Suite 200
Palo Alto,  CA  94303
Applicant Contact ROBIN BUSH SAWAMURA
Correspondent
Health Hero Network, Inc.
2400 Geng Rd. Suite 200
Palo Alto,  CA  94303
Correspondent Contact ROBIN BUSH SAWAMURA
Regulation Number870.2910
Classification Product Code
DRG  
Date Received01/14/2008
Decision Date 02/05/2008
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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