510(k) K121599 ยท KOC Accessories, Blood Circuit, Hemodialysis
CRIT-LINE CLIP (CLIC)
| Applicant | Fresenius Medical Care-North America, Waltham MA, US |
| Decision | Substantially Equivalent, Nov 9, 2012 |
| Received | Jun 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121599
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Crit Line in a Clip (CLiC). CliC P/N: CL 10041001
CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysi Terminated |
KOC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.