Clearance Summary
MRI COMPATIBLE MONITOR AND ACCESSORIES received FDA 510(k) clearance under submission number K980362, 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 1998-06-30.
- Submission: K980362
- Applicant / Sponsor: Datex-Engstrom, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 1998-06-30
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.