Clearance Summary
BIG BEN SQUARE, BIG BEN ROUND received FDA 510(k) clearance under submission number K972301, sponsored by Rudolf Riester GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1997-09-17.
- Submission: K972301
- Applicant / Sponsor: Rudolf Riester GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 1997-09-17
Classification & Regulation
This clearance is catalogued under FDA product code DXQ and 21 CFR 870.1120, within the Cardiovascular review panel as a Class II device.