Clearance Summary
ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER received FDA 510(k) clearance under submission number K121775, sponsored by Vital Signs, Inc., A GE Healthcare Company. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2012-11-28.
- Submission: K121775
- Applicant / Sponsor: Vital Signs, Inc., A GE Healthcare Company
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2012-11-28
Classification & Regulation
This clearance is catalogued under FDA product code LGZ and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.