Clearance Summary
Personal Kinetigraph (PKG) System Gen 2 Plus received FDA 510(k) clearance under submission number K211887, sponsored by Gkc Manufacturing Pty, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2022-03-11.
- Submission: K211887
- Applicant / Sponsor: Gkc Manufacturing Pty, Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1950
- Decision date: 2022-03-11
Classification & Regulation
This clearance is catalogued under FDA product code GYD and 21 CFR 882.1950, within the Neurology review panel as a Class II device.