The following data is part of a premarket notification filed by Novo Nordisk Inc. with the FDA for Novopen Echo Dial-a-dose Insulin Delivery Device (pen Injector).
| Device ID | K182387 |
| 510k Number | K182387 |
| Device Name: | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) |
| Classification | Syringe, Piston |
| Applicant | Novo Nordisk Inc. 800 Scudders Mill Rd Plainsboro, NJ 08536 |
| Contact | Elizabeth D'amato |
| Correspondent | Elizabeth D'amato Novo Nordisk Inc. 800 Scudders Mill Rd 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 | 2018-09-04 |
| Decision Date | 2018-12-17 |
| Summary: | summary |