K182387 is an FDA 510(k) clearance for the NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector). This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Novo Nordisk, Inc. (Plainsboro, US). The FDA issued a Cleared decision on December 17, 2018, 104 days after receiving the submission on September 4, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K182387 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2018 |
| Decision Date | December 17, 2018 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |