Clearance Summary
BIG BEN received FDA 510(k) clearance under submission number K942650, sponsored by Rud 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 1994-08-15.
- Submission: K942650
- Applicant / Sponsor: Rud Riester GmbH & CO KG
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1994-08-15
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.