510(k) K072950 ยท KRE Analyzer, Pacemaker Generator Function, Indirect
CYGNUS 12 LEAD ECG MODULE
| Applicant | Cygnus, LLC, Paterson NJ, US |
| Decision | Substantially Equivalent, Aug 22, 2008 |
| Received | Oct 18, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072950
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.