Clearance Summary
TBI STAND received FDA 510(k) clearance under submission number K972709, sponsored by Mick Radio-Nuclear Instruments, 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 1997-10-16.
- Submission: K972709
- Applicant / Sponsor: Mick Radio-Nuclear Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 1997-10-16
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.