510(k) K821139 ยท FIR Pump, Blood, Extra-Luminal
SPS-SINGLE PATIENT SYSTEM
| Applicant | Extracorporeal Medical Specialities, Inc., King Of Prussia PA, US |
| Decision | Substantially Equivalent, May 10, 1982 |
| Received | Apr 21, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821139
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.