510(k) K101833 ยท OWB Interventional Fluoroscopic X-Ray System
INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
| Applicant | Infimed, Inc., Great Neck NY, US |
| Decision | Substantially Equivalent, Jul 23, 2010 |
| Received | Jul 1, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101833
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.