Clearance Summary
MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2 received FDA 510(k) clearance under submission number K993584, sponsored by Nellcor Puritan Bennett France Dvpt.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2000-03-07.
- Submission: K993584
- Applicant / Sponsor: Nellcor Puritan Bennett France Dvpt.
- Clearance pathway: Abbreviated
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2000-03-07
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.