Clearance Summary
REMREST HEATED HUMIDIFIER received FDA 510(k) clearance under submission number K050990, sponsored by Medical Industries America, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2005-05-02.
- Submission: K050990
- Applicant / Sponsor: Medical Industries America, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5450
- Decision date: 2005-05-02
Classification & Regulation
This clearance is catalogued under FDA product code BTT and 21 CFR 868.5450, within the Anesthesiology review panel as a Class II device.