K123766 is an FDA 510(k) clearance for the NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN. 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 August 15, 2013, 251 days after receiving the submission on December 7, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K123766 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2012 |
| Decision Date | August 15, 2013 |
| Days to Decision | 251 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 |