510(k) K133797 ยท OAS X-Ray, Tomography, Computed, Dental
QMASTER-H/REVO
| Applicant | Telesystems Co., Ltd., Ormond Beach FL, US |
| Decision | Substantially Equivalent, Sep 4, 2014 |
| Received | Dec 13, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133797
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.