Clearance Summary
BOOST, MICE, GAMESYS. received FDA 510(k) clearance under submission number K924416, sponsored by Penny and Giles Biometrics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1993-06-15.
- Submission: K924416
- Applicant / Sponsor: Penny and Giles Biometrics , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.1500
- Decision date: 1993-06-15
Classification & Regulation
This clearance is catalogued under FDA product code KQX and 21 CFR 888.1500, within the Orthopedic review panel as a Class I device.