510(k) K935958 ยท KOC Accessories, Blood Circuit, Hemodialysis
CRIT-LINE BLOOD CHAMBER WITH E-BEAM
| Applicant | In-Line Diagnostics Corp., Riverdale UT, US |
| Decision | Substantially Equivalent, Jan 19, 1995 |
| Received | Nov 26, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935958
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2015 | Fresenius Medical Care Holdings, Inc. CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters
Model: CL10021021 Terminated |
KOC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.