Clearance Summary
ROGS received FDA 510(k) clearance under submission number K131016, sponsored by Molecular Products , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2013-11-27.
- Submission: K131016
- Applicant / Sponsor: Molecular Products , Ltd.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2013-11-27
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.