510(k) K964801 ยท HAW Neurological Stereotaxic Instrument
OPTICAL TRACKING SYSTEM (OTS)
| Applicant | Radionics Software Applications, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Jun 2, 1997 |
| Received | Nov 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964801
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.