510(k) K192004 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Eko Analysis Software
| Applicant | Eko Devices, Inc., Berkeley CA, US |
| Decision | Substantially Equivalent, Jan 15, 2020 |
| Received | Jul 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192004
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.