Clearance Summary
INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM received FDA 510(k) clearance under submission number K080908, sponsored by Innercool Therapies, Inc.- A Delaware Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-10-17.
- Submission: K080908
- Applicant / Sponsor: Innercool Therapies, Inc.- A Delaware Corporation
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5900
- Decision date: 2008-10-17
Classification & Regulation
This clearance is catalogued under FDA product code NCX and 21 CFR 870.5900, within the Cardiovascular review panel as a Class II device.