K211887 is an FDA 510(k) clearance for the Personal Kinetigraph (PKG) System Gen 2 Plus. This device is classified as a Transducer, Tremor (Class II - Special Controls, product code GYD).
Submitted by Gkc Manufacturing Pty, Ltd. (Melbourne, AU). The FDA issued a Cleared decision on March 11, 2022, 263 days after receiving the submission on June 21, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1950.
| 510(k) Number | K211887 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2021 |
| Decision Date | March 11, 2022 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GYD - Transducer, Tremor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1950 |