510(k) K022360 ยท DTA Tester, Pacemaker Electrode Function
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., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Jan 27, 2003 |
| Received | Jul 19, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022360
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.