Clearance Summary
WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System received FDA 510(k) clearance under submission number K162225, sponsored by Welldoc, 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 2016-11-22.
- Submission: K162225
- Applicant / Sponsor: Welldoc, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2016-11-22
Classification & Regulation
This clearance is catalogued under FDA product code MRZ and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.