Clearance Summary
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) received FDA 510(k) clearance under submission number K170982, sponsored by Smiths Medical Ads, 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 2017-08-24.
- Submission: K170982
- Applicant / Sponsor: Smiths Medical Ads, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2017-08-24
Classification & Regulation
This clearance is catalogued under FDA product code MEA and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.