510(k) K192303 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ExactVu High Resolution Micro-Ultrasound System
| Applicant | Exact Imaging, Inc., Markham, CA |
| Decision | Substantially Equivalent, Oct 1, 2019 |
| Received | Aug 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192303
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.