510(k) K161302 ยท DPS Electrocardiograph
PC ECG
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Jul 1, 2016 |
| Received | May 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161302
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.