510(k) K043612 ยท EHD Unit, X-Ray, Extraoral With Timer
ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D
| Applicant | Instrumentarium Corp. Imaging Division, Milwaukee WI, US |
| Decision | Substantially Equivalent, Feb 9, 2005 |
| Received | Dec 30, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043612
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.