Clearance Summary
CS/3 COMPACT AIRWAY MODULE, M-COVX received FDA 510(k) clearance under submission number K982091, sponsored by Datex-Engstrom, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-12-22.
- Submission: K982091
- Applicant / Sponsor: Datex-Engstrom, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1998-12-22
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.