510(k) K001431 ยท HAW Neurological Stereotaxic Instrument
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
| Applicant | Radionics, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, May 17, 2000 |
| Received | May 8, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001431
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.