510(k) K210432 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
LELTEK Ultrasound Imaging System (Model: LU700 Series)
| Applicant | Leltek, Inc., New Taipei City, TW |
| Decision | Substantially Equivalent, Nov 3, 2021 |
| Received | Feb 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210432
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.