Clearance Summary
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) received FDA 510(k) clearance under submission number K182387, sponsored by Novo Nordisk, 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 2018-12-17.
- Submission: K182387
- Applicant / Sponsor: Novo Nordisk, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2018-12-17
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.