510(k) K182387
K182387 is an FDA 510(k) premarket notification submitted by Novo Nordisk, Inc. for the device "NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)". The FDA issued a decision of Substantially Equivalent on Dec 17, 2018. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Novo Nordisk, Inc. has 14 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 17, 2018
- Date Received
- Sep 4, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)