The following data is part of a premarket notification filed by Novo Nordisk Inc. with the FDA for Novopen Echo, A Dial A Dose Insulin Delivery Pen.
Device ID | K123766 |
510k Number | K123766 |
Device Name: | NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN |
Classification | Syringe, Piston |
Applicant | NOVO NORDISK INC. P.O. BOX 846 Plainsboro, NJ 08536 |
Contact | Lois Kotkoskie, Ph. D |
Correspondent | Lois Kotkoskie, Ph. D NOVO NORDISK INC. P.O. BOX 846 Plainsboro, NJ 08536 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-07 |
Decision Date | 2013-08-15 |
Summary: | summary |