510(k) K811977 ยท KOC Accessories, Blood Circuit, Hemodialysis
HEMASITE ACCESS MONITOR (TENT.) #RS-8200
| Applicant | Renal Systems, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 31, 1981 |
| Received | Jul 13, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811977
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.