AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP


Device Classification Name

permanent pacemaker electrode

510(k) Number K021217
Device Name AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP
Original Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, 
OR 
97035

Original Contact jon brumbaugh
Regulation Number 870.3680
Classification Product Code
DTB  
Date Received 04/17/2002
Decision Date 05/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No