Clearance Summary
MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM received FDA 510(k) clearance under submission number K131247, sponsored by Mfs - Medical Flow Systems, Ltd.. 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 2013-08-14.
- Submission: K131247
- Applicant / Sponsor: Mfs - Medical Flow Systems, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2013-08-14
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.