510(k) K053011 ยท DRX Electrode, Electrocardiograph
PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20
| Applicant | Bio Protech, Inc., Crofton MD, US |
| Decision | Substantially Equivalent, Dec 14, 2005 |
| Received | Oct 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053011
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.