510(k) K163138 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Clarius Ultrasound System
| Applicant | Clarius Mobile Health Corp., Burnaby, CA |
| Decision | Substantially Equivalent, Nov 30, 2016 |
| Received | Nov 9, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K163138
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.