ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP


Device Classification Name

permanent pacemaker electrode

510(k) Number K023205
Device Name ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
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 09/25/2002
Decision Date 04/24/2003
Decision

(ST)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No