510(k) K213282 ยท EHD Unit, X-Ray, Extraoral With Timer
ERI Handheld Dental X-ray System (Model AG100)
| Applicant | Energy Resources International Co., Ltd. Hsinchu Branch, Zhubei City, TW |
| Decision | Substantially Equivalent, Apr 4, 2022 |
| Received | Oct 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213282
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.