Clearance Summary
INFANT FLOW SYSTEM, MODEL M672P received FDA 510(k) clearance under submission number K011516, sponsored by Eme (Electro Medical Equipment) , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2001-06-08.
- Submission: K011516
- Applicant / Sponsor: Eme (Electro Medical Equipment) , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2001-06-08
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.