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 |