Clearance Summary
FRONING GUIDANCE SYSTEM #TX-8200 received FDA 510(k) clearance under submission number K823675, sponsored by Today'S Machining & Design, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1983-01-05.
- Submission: K823675
- Applicant / Sponsor: Today'S Machining & Design, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 1983-01-05
Classification & Regulation
This clearance is catalogued under FDA product code HAW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.