Clearance Summary
FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE received FDA 510(k) clearance under submission number K950044, sponsored by Fukuda Denshi USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1995-09-15.
- Submission: K950044
- Applicant / Sponsor: Fukuda Denshi USA, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 1995-09-15
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.