Clearance Summary
HOME-AWAY SYSTEM, MODEL 1041 received FDA 510(k) clearance under submission number K042944, sponsored by In-X Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2005-04-15.
- Submission: K042944
- Applicant / Sponsor: In-X Corporation
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2005-04-15
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.