510(k) K911043 ยท ITX Transducer, Ultrasonic, Diagnostic
HEMISPHERE MULTIPLANE ENDORECTAL PROBE
| Applicant | Pie Medical Equipment B.V., Maastricht, NL |
| Decision | Substantially Equivalent, Oct 9, 1991 |
| Received | Mar 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911043
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.