510(k) K241161 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound
| Applicant | Leltek, Inc., New Taipei City, TW |
| Decision | Substantially Equivalent, Sep 11, 2024 |
| Received | Apr 26, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K241161
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.