HERO


Device Classification Name

electrocardiograph

510(k) Number K021230
Device Name HERO
Original Applicant
MEDICAL DECISION NETWORKS
2300 commonwealth dr.
charlottesville, 
VA 
22901

Original Contact william e king
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 04/18/2002
Decision Date 05/09/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No