510(k) K946318 ยท GXY Electrode, Cutaneous
MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE
| Applicant | Physiometrix, Inc., North Billerica MA, US |
| Decision | Substantially Equivalent, Apr 24, 1995 |
| Received | Dec 28, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946318
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.