Clearance Summary
ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML received FDA 510(k) clearance under submission number K020485, sponsored by Baxter Healthcare Corp. 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 2002-03-12.
- Submission: K020485
- Applicant / Sponsor: Baxter Healthcare Corp
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5025
- Decision date: 2002-03-12
Classification & Regulation
This clearance is catalogued under FDA product code KPE and 21 CFR 880.5025, within the General Hospital review panel as a Class II device.