510(k) K173780 ยท LLZ System, Image Processing, Radiological
EchoMD Automated Ejection Fraction Software
| Applicant | Bay Labs, Inc., San Francisco CA, US |
| Decision | Substantially Equivalent, Jun 14, 2018 |
| Received | Dec 12, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173780
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.