HERO, VERSION 2.0


Device Classification Name

electrocardiograph

510(k) Number K081473
Device Name HERO, VERSION 2.0
Applicant
MEDICAL PREDICTIVE SCIENCE CORP.
2246 ivy rd., suite 17
charlottesville, 
VA 
22903

Applicant Contact william e king
Correspondent
MEDICAL PREDICTIVE SCIENCE CORP.
2246 ivy rd., suite 17
charlottesville, 
VA 
22903

Correspodent Contact william e king
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 05/27/2008
Decision Date 06/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No