510(k) K974210 ยท MOT Irradiator, Blood To Prevent Graft Versus Host Disease
SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
| Applicant | Rad-Source, Inc., Coral Springs FL, US |
| Decision | Substantially Equivalent, Mar 30, 1998 |
| Received | Nov 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974210
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Rad-Source Technologies, Inc. RAD SOURCE RS 3000 Blood Irradiator Three Bag Option Terminated |
MOT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.