510(k) K210317 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System
| Applicant | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui), Shantou, CN |
| Decision | Substantially Equivalent, Aug 19, 2021 |
| Received | Feb 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210317
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.