Clearance Summary
PORTABLE OXYGEN GENERATOR SYSTEM received FDA 510(k) clearance under submission number K062153, sponsored by Molecular Products , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2006-11-21.
- Submission: K062153
- Applicant / Sponsor: Molecular Products , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2006-11-21
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.