Clearance Summary
ICU SARACAP received FDA 510(k) clearance under submission number K881093, 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 1988-06-24.
- Submission: K881093
- Applicant / Sponsor: Ppg/Applied Resources, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 1988-06-24
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.