510(k) K140086 ยท GYD Transducer, Tremor
PERSONAL KINETIGRAPH (PKG) SYSTEM
| Applicant | Gkc Manufacturing Pty, Ltd., Rockville MD, US |
| Decision | Substantially Equivalent, Aug 22, 2014 |
| Received | Jan 14, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140086
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.