Clearance Summary
CSD 200/300/400/500 DYNAMOMETER received FDA 510(k) clearance under submission number K931321, sponsored by John Chatillon & Sons, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1994-02-15.
- Submission: K931321
- Applicant / Sponsor: John Chatillon & Sons, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1240
- Decision date: 1994-02-15
Classification & Regulation
This clearance is catalogued under FDA product code LBB and 21 CFR 888.1240, within the Orthopedic review panel as a Class II device.