510(k) K103448 ยท KPR System, X-Ray, Stationary
BRIVO XR385
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 12, 2011 |
| Received | Nov 24, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103448
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2018 | GE Healthcare, LLC Brivo XR385, model 5215463, Digital Diagnostic Radiographic System Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.