510(k) K965013 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
DIGISCOPE RX-2 (9 OPTION)
| Applicant | Medirex, Inc., Wellesley Hills MA, US |
| Decision | Substantially Equivalent, Jan 17, 1997 |
| Received | Dec 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965013
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.