The following data is part of a premarket notification filed by Gkc Manufacturing Pty Ltd with the FDA for Personal Kinetigraph (pkg) System Gen 2 Plus.
| Device ID | K211887 |
| 510k Number | K211887 |
| Device Name: | Personal Kinetigraph (PKG) System Gen 2 Plus |
| Classification | Transducer, Tremor |
| Applicant | GKC Manufacturing Pty Ltd Level 9, 31 Queen Street Melbourne, AU 3000 |
| Contact | Jim Quackenbush |
| Correspondent | Kathy Herzog DuVal & Associates, P.A. Suite 1820, Medical Arts Building 825 Nicollet Mall Minneapolis, MN 55402 |
| Product Code | GYD |
| Subsequent Product Code | ISD |
| Subsequent Product Code | NXQ |
| CFR Regulation Number | 882.1950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-21 |
| Decision Date | 2022-03-11 |