Clearance Summary
MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0 received FDA 510(k) clearance under submission number K141193, sponsored by Smiths Medical Asd, Inc.. 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 2014-07-25.
- Submission: K141193
- Applicant / Sponsor: Smiths Medical Asd, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2014-07-25
Classification & Regulation
This clearance is catalogued under FDA product code PHC and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.