Clearance Summary
LOW FLUID ALARM received FDA 510(k) clearance under submission number K080704, sponsored by Em-Tec GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2008-04-17.
- Submission: K080704
- Applicant / Sponsor: Em-Tec GmbH
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2420
- Decision date: 2008-04-17
Classification & Regulation
This clearance is catalogued under FDA product code FLN and 21 CFR 880.2420, within the General Hospital review panel as a Class II device.