510(k) K152396 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
S12 Digital Color Doppler Ultrasound System
| Applicant | Sonoscape Medical Corp., Shenzhen, CN |
| Decision | Substantially Equivalent, Sep 3, 2015 |
| Received | Aug 24, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152396
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.