510(k) K901332 ยท DTC Analyzer, Pacemaker Generator Function
PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE
| Applicant | Biotronik, GmbH & Co., Lake Oswego OR, US |
| Decision | Substantially Equivalent, May 9, 1990 |
| Received | Mar 22, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901332
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.