510(k) K981964 ยท DRX Electrode, Electrocardiograph
MEDI-TRACE 4103 NEONATAL ELECTRODE
| Applicant | Graphic Controls Corp., Buffalo NY, US |
| Decision | Substantially Equivalent, Nov 13, 1998 |
| Received | Jun 4, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981964
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.