510(k) K973540 ยท IYE Accelerator, Linear, Medical
ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS
| Applicant | Elekta Oncology Systems, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Dec 17, 1997 |
| Received | Sep 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973540
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.