EKGCARD SYSTEM


Device Classification Name

electrocardiograph

510(k) Number K030535
Device Name EKGCARD SYSTEM
Applicant
QRS DIAGNOSTIC, LLC.
14755 27th ave.north
plymouth, 
MN 
55447

Applicant Contact brad sorenson
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 02/20/2003
Decision Date 06/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No