510(k) K181195 ยท ORR Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
ClearPoint System
| Applicant | Mri Interventions, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Nov 2, 2018 |
| Received | May 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181195
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.