Clearance Summary
PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US received FDA 510(k) clearance under submission number K020886, sponsored by Tyco Healthcare Nancy. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2002-11-01.
- Submission: K020886
- Applicant / Sponsor: Tyco Healthcare Nancy
- Clearance pathway: Abbreviated
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2002-11-01
Classification & Regulation
This clearance is catalogued under FDA product code BZD and 21 CFR 868.5905, within the Anesthesiology review panel as a Class II device.