510(k) K191235 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Leltek Ultrasound Imaging System
| Applicant | Leltek, Inc., New Taipei City, TW |
| Decision | Substantially Equivalent, Feb 12, 2020 |
| Received | May 8, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191235
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.