510(k) K161431 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
SimplECG
| Applicant | Nanowear, Inc., Brooklyn NY, US |
| Decision | Substantially Equivalent, Nov 30, 2016 |
| Received | May 24, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161431
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.