K022360

Substantially Equivalent

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.

Applicant: Biotronik, Inc.
Product code: DTA
Advisory panel: Cardiovascular
Date received: 2002-07-19
Decision date: 2003-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.