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.— 510(k) K022360
Substantially EquivalentBiotronik, Inc.
FDA 510(k) clearance K022360 for 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., Substantially Equivalent on 2003-01-27. Applicant: Biotronik, Inc..
Clearance details
- Applicant
- Biotronik, Inc.
- Product code
- Code DTA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Oswego, OR, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.