510(k) K915632 ยท KRE Analyzer, Pacemaker Generator Function, Indirect
PACEART CPTS-86/12
| Applicant | Paceart, Inc., Wayne NJ, US |
| Decision | Substantially Equivalent, Apr 14, 1992 |
| Received | Dec 17, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915632
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.