Clearance Summary
BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO received FDA 510(k) clearance under submission number K050006, sponsored by C.R. Bard, 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 2005-05-27.
- Submission: K050006
- Applicant / Sponsor: C.R. Bard, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2060
- Decision date: 2005-05-27
Classification & Regulation
This clearance is catalogued under FDA product code DRQ and 21 CFR 870.2060, within the Cardiovascular review panel as a Class II device.