510(k) K122582 ยท EHD Unit, X-Ray, Extraoral With Timer
DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C)
| Applicant | Denterprise International, Inc., Ormond Beach FL, US |
| Decision | Substantially Equivalent, Dec 7, 2012 |
| Received | Aug 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122582
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.