510(k) K101660 ยท DSA Cable, Transducer And Electrode, Patient, (Including Connector)
ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8
| Applicant | Kepler Medtec, Ashland MA, US |
| Decision | Substantially Equivalent, Aug 11, 2010 |
| Received | Jun 14, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101660
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.