510(k) K162602
K162602 is an FDA 510(k) premarket notification submitted by Novo Nordisk, Inc. for the device "NovoPen Echo". The FDA issued a decision of Substantially Equivalent on Oct 18, 2016. 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
- Oct 18, 2016
- Date Received
- Sep 19, 2016
- Clearance Type
- Special
- 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)