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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K060843
Device Name MODIFICATION TO HEALTH BUDDY APPLIANCE
Applicant
HEALTH HERO NETWORK, INC.
2000 SEAPORT BLVD, SUITE 400
REDWOOD CITY,  CA  94063
Applicant Contact ROBIN BUSH
Correspondent
HEALTH HERO NETWORK, INC.
2000 SEAPORT BLVD, SUITE 400
REDWOOD CITY,  CA  94063
Correspondent Contact ROBIN BUSH
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/28/2006
Decision Date 04/20/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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