Clearance Summary
SARA AGIE MONITOR received FDA 510(k) clearance under submission number K874724, sponsored by Ppg/Applied Resources, 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 1988-03-29.
- Submission: K874724
- Applicant / Sponsor: Ppg/Applied Resources, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 1988-03-29
Classification & Regulation
This clearance is catalogued under FDA product code CCK and 21 CFR 868.1400, within the Anesthesiology review panel as a Class II device.