510(k) K150823 ยท MUH System, X-Ray, Extraoral Source, Digital
EDLENi Intra-Oral Sensor
| Applicant | Edlen Imaging, LLC, Scottsdale AZ, US |
| Decision | Substantially Equivalent, Aug 26, 2015 |
| Received | Mar 27, 2015 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K150823
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.