MODIFICATION TO:HEALTH BUDDY APPLIANCE


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 road
suite 200
palo alto, 
CA 
94303

Applicant Contact robin bush sawamura
Correspondent
HEALTH HERO NETWORK, INC.
2400 geng road
suite 200
palo alto, 
CA 
94303

Correspodent Contact robin bush sawamura
Regulation Number 870.2910
Classification Product Code
DRG  
Date Received 01/14/2008
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