Clearance Summary
PAINBUSTER INFUSION SYSTEM received FDA 510(k) clearance under submission number K980558, sponsored by I-Flow Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1998-05-28.
- Submission: K980558
- Applicant / Sponsor: I-Flow Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1998-05-28
Classification & Regulation
This clearance is catalogued under FDA product code MEB and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.