PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE


Device Classification Name

catheter, electrode recording, or probe, electrode recording

510(k) Number K021421
Device Name PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE
Original Applicant
TZ MEDICAL, INC.
7272 s.w. durham rd., #800
portland, 
OR 
97224

Original Contact madalyn duncan
Regulation Number 870.1220
Classification Product Code
DRF  
Date Received 05/03/2002
Decision Date 04/18/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No