Clearance Summary
IPC-BOOT received FDA 510(k) clearance under submission number K070324, sponsored by C-Boot , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-05-03.
- Submission: K070324
- Applicant / Sponsor: C-Boot , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 2007-05-03
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.