510(k) K190591 ยท MUI Media, Coupling, Ultrasound
Safergel Sterile Ultrasound Gel
| Applicant | Safersonic Us, Inc., Highland Park IL, US |
| Decision | Substantially Equivalent, Oct 4, 2019 |
| Received | Mar 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190591
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.