510(k) K022630 ยท EHD Unit, X-Ray, Extraoral With Timer
MODIFICATION TO FOCUS
| Applicant | Instrumentarium Corp., Milwaukee WI, US |
| Decision | Substantially Equivalent, Oct 9, 2002 |
| Received | Aug 7, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022630
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2014 | Instrumentarium Dental, PaloDEx Group Oy The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOC Terminated |
EHD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.