510(k) K160853 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System
| Applicant | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui), Shantou, CN |
| Decision | Substantially Equivalent, Jun 27, 2016 |
| Received | Mar 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160853
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.