Clearance Summary
EDI 320 received FDA 510(k) clearance under submission number K873599, sponsored by Cybex. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1987-10-16.
- Submission: K873599
- Applicant / Sponsor: Cybex
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.1500
- Decision date: 1987-10-16
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.