Clearance Summary
TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR received FDA 510(k) clearance under submission number K003982, sponsored by Magnetic Resonance Equipment Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2001-01-26.
- Submission: K003982
- Applicant / Sponsor: Magnetic Resonance Equipment Corp.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 2001-01-26
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.