K140086 is an FDA 510(k) clearance for the PERSONAL KINETIGRAPH (PKG) SYSTEM. This device is classified as a Transducer, Tremor (Class II - Special Controls, product code GYD).
Submitted by Gkc Manufacturing Pty, Ltd. (Rockville, US). The FDA issued a Cleared decision on August 22, 2014, 220 days after receiving the submission on January 14, 2014.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1950.
| 510(k) Number | K140086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 2014 |
| Decision Date | August 22, 2014 |
| Days to Decision | 220 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 |