510(k) K002053 ยท HAW Neurological Stereotaxic Instrument
NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004
| Applicant | Orthosoft, Inc., Montreal, Quebec, CA |
| Decision | Substantially Equivalent, Aug 3, 2000 |
| Received | Jul 6, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002053
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.