510(k) K201425 ยท ITX Transducer, Ultrasonic, Diagnostic
Disposable Intraoperative Probe (DIOP8)
| Applicant | Huntleigh Healthcare Limited, Cardiff, GB |
| Decision | Substantially Equivalent, Feb 19, 2021 |
| Received | May 29, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201425
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2022 | Huntleigh Healthcare Ltd. HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8 Terminated |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.