Clearance Summary
INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR received FDA 510(k) clearance under submission number K983250, sponsored by Magnetic Resonance Equipment Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-12-12.
- Submission: K983250
- Applicant / Sponsor: Magnetic Resonance Equipment Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1110
- Decision date: 1999-12-12
Classification & Regulation
This clearance is catalogued under FDA product code DSK and 21 CFR 870.1110, within the Cardiovascular review panel as a Class II device.