510(k) K853038 ยท DRX Electrode, Electrocardiograph
DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES
| Applicant | Bio-Detek, Inc., Mansfield MA, US |
| Decision | Substantially Equivalent, Jan 7, 1986 |
| Received | Jul 19, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853038
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.