510(k) K222365 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Leltek Ultrasound Imaging System (Model: LU700 Series)
| Applicant | Leltek, Inc., New Taipei City, TW |
| Decision | Substantially Equivalent, Oct 25, 2022 |
| Received | Aug 4, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222365
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.