PACEART SYSTEM


Device Classification Name

electrocardiograph

510(k) Number K024278
Device Name PACEART SYSTEM
Original Applicant
MEDTRONIC VASCULAR
7000 central ave. n.e.
minneapolis, 
MN 
55432

Original Contact karen ruth-jarmon
Regulation Number 870.2340
Classification Product Code
DPS  
Subsequent Product Codes
DXH   KRE  
Date Received 12/23/2002
Decision Date 05/29/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls