510(k) K100315 ยท DRX Electrode, Electrocardiograph
12 LEAD GLOVE
| Applicant | I Needmd, Inc., New York NY, US |
| Decision | Substantially Equivalent, Apr 23, 2010 |
| Received | Feb 4, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100315
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.