510(k) K912172 ยท KRB Probe, Thermodilution
SAFEWEDGE(TM) RELIEF VALVE DEVICE
| Applicant | Sunscope Intl., Inc., Westlake Village CA, US |
| Decision | Substantially Equivalent, Sep 27, 1991 |
| Received | May 16, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912172
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.