Clearance Summary
R-MADE HEAD/ARM SUPPORT received FDA 510(k) clearance under submission number K923775, sponsored by R-Made, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1992-10-20.
- Submission: K923775
- Applicant / Sponsor: R-Made, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1992-10-20
Classification & Regulation
This clearance is catalogued under FDA product code IXQ and 21 CFR 892.1980, within the Radiology review panel as a Class II device.