Clearance Summary
HAFCON (FLOURO FOOTSWITCH) received FDA 510(k) clearance under submission number K901671, sponsored by B & H Research Instruments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1990-08-08.
- Submission: K901671
- Applicant / Sponsor: B & H Research Instruments
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1990-08-08
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.