510(k) K013428 ยท HAW Neurological Stereotaxic Instrument
MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM
| Applicant | Ohio Medical Instrument Co., Inc., Wrentham MA, US |
| Decision | Substantially Equivalent, Apr 4, 2002 |
| Received | Oct 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013428
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.