510(k) K141497 ยท EHD Unit, X-Ray, Extraoral With Timer
PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)
| Applicant | Osstem Implant Co., Ltd., Fariless Hills PA, US |
| Decision | Substantially Equivalent, Aug 26, 2014 |
| Received | Jun 6, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141497
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.