510(k) K946018 ยท GZL Electrode, Depth
TENS-IT, FITTRONIC II, (MORE LATER)
| Applicant | Ems, Inc., Pen Valley CA, US |
| Decision | Substantially Equivalent, Nov 9, 1995 |
| Received | Dec 9, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946018
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.