510(k) K081664 ยท EHD Unit, X-Ray, Extraoral With Timer
NOMAD PRO X-RAY SYSTEM
| Applicant | Aribex, Inc., Orem UT, US |
| Decision | Substantially Equivalent, Jun 23, 2008 |
| Received | Jun 13, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081664
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2016 | Aribex Inc NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ray System - Europe, Part Number 08500013; NOMAD Pro X-Ray System Terminated |
EHD | None listed |
| Sep 2, 2016 | Aribex Inc NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray System, Part Number 08500023; NOMAD Pro2 Vet Package Terminated |
EHD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.