510(k) K033613 ยท DTA Tester, Pacemaker Electrode Function
MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Dec 8, 2003 |
| Received | Nov 17, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033613
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.