Clearance Summary
MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 received FDA 510(k) clearance under submission number K021576, sponsored by Mercury Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2002-11-04.
- Submission: K021576
- Applicant / Sponsor: Mercury Medical
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 2002-11-04
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.