510(k) K161937 ยท KPR System, X-Ray, Stationary
CuattroDR
| Applicant | Cuattro, LLC, Loveland CO, US |
| Decision | Substantially Equivalent, Oct 6, 2016 |
| Received | Jul 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161937
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2019 | Cuattro LLC CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0 Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.