510(k) K221568 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
KOLO Evolution XHD Series Ultrasound Diagnostic System
| Applicant | Kolo Medical (Suzhou) Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Sep 12, 2022 |
| Received | May 31, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221568
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.