Gkc Manufacturing Pty, Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K211887 | Personal Kinetigraph (PKG) System Gen 2 Plus | March 11, 2022 |
| K161717 | Personal Kinetigraph (PKG) System | September 20, 2016 |
| K140086 | PERSONAL KINETIGRAPH (PKG) SYSTEM | August 22, 2014 |