510(k) K222460 ยท ITX Transducer, Ultrasonic, Diagnostic
Intraoperative Ultrasound Probe Cover
| Applicant | Exact Medical Manufacturing, Changzhou Jiangsu, CN |
| Decision | Substantially Equivalent, May 12, 2023 |
| Received | Aug 15, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222460
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.