ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.


Device Classification Name

tester, pacemaker electrode function

510(k) Number K022360
Device Name ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.
Original Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, 
OR 
97035

Original Contact jon brumbaugh
Regulation Number 870.3720
Classification Product Code
DTA  
Date Received 07/19/2002
Decision Date 01/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No