510(k) K981083 ยท DTB Permanent Pacemaker Electrode
RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Jul 22, 1998 |
| Received | Mar 24, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981083
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.