510(k) K211887 ยท GYD Transducer, Tremor
Personal Kinetigraph (PKG) System Gen 2 Plus
| Applicant | Gkc Manufacturing Pty, Ltd., Melbourne, AU |
| Decision | Substantially Equivalent, Mar 11, 2022 |
| Received | Jun 21, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211887
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.