Clearance Summary
PEARL DIABETES MANAGEMENT SYSTEM received FDA 510(k) clearance under submission number K122483, sponsored by Asante Solutions, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2013-01-03.
- Submission: K122483
- Applicant / Sponsor: Asante Solutions, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2013-01-03
Classification & Regulation
This clearance is catalogued under FDA product code LZG and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.