CARDIS


Device Classification Name

computer, diagnostic, programmable

510(k) Number K023015
Device Name CARDIS
Original Applicant
SCHWARZER GMBH
baermannstrasse 38
munich, 

DE

d-81245

Original Contact eike kinzel
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 09/10/2002
Decision Date 09/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No