510(k) K050443 ยท DRX Electrode, Electrocardiograph
ACCU-LEAD
| Applicant | Kentec Medical, Inc., Lake Forest CA, US |
| Decision | Substantially Equivalent, Sep 2, 2005 |
| Received | Feb 22, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050443
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.