Clearance Summary
GONIOMETER AND BIOMEDICAL RECORDER SYSTEM received FDA 510(k) clearance under submission number K884003, sponsored by Penny & Giles Blackwood , 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 1988-12-19.
- Submission: K884003
- Applicant / Sponsor: Penny & Giles Blackwood , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.1500
- Decision date: 1988-12-19
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.