Clearance Summary
Rugged Oxygen Generator (ROG) (RO01-00001) received FDA 510(k) clearance under submission number K240561, 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 2024-12-06.
- Submission: K240561
- Applicant / Sponsor: Molecular Products , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2024-12-06
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.