Clearance Summary
RT40 RADIO TRANSLUCENT received FDA 510(k) clearance under submission number K912714, sponsored by Bio-Detek, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1991-07-25.
- Submission: K912714
- Applicant / Sponsor: Bio-Detek, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 1991-07-25
Classification & Regulation
This clearance is catalogued under FDA product code DRX and 21 CFR 870.2360, within the Cardiovascular review panel as a Class II device.