510(k) K113748 ยท HBL Holder, Head, Neurosurgical (Skull Clamp)
IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
| Applicant | Imris, Inc., Winnipeg, Mb, CA |
| Decision | Substantially Equivalent, Mar 23, 2012 |
| Received | Dec 21, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113748
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2019 | Deerfield Imaging, Inc. IMRIS MR/X-ray head fixation device, Model HFD200 Terminated |
HBL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.