510(k) K010548 ยท HAW Neurological Stereotaxic Instrument
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
| Applicant | Radionics, A Division of Tyco Healthcare Group LP, Burlington MA, US |
| Decision | Substantially Equivalent, Mar 12, 2001 |
| Received | Feb 26, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010548
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.