Clearance Summary
HOME-AWAY SYSTEM received FDA 510(k) clearance under submission number K004047, sponsored by In-X Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2001-12-18.
- Submission: K004047
- Applicant / Sponsor: In-X Corp.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2001-12-18
Classification & Regulation
This clearance is catalogued under FDA product code CAW and 21 CFR 868.5440, within the Anesthesiology review panel as a Class II device.