NovoPen Echo
Syringe, Piston
Novo Nordisk Inc.
The following data is part of a premarket notification filed by Novo Nordisk Inc. with the FDA for Novopen Echo.
Pre-market Notification Details
| Device ID | K162602 |
| 510k Number | K162602 |
| Device Name: | NovoPen Echo |
| Classification | Syringe, Piston |
| Applicant | Novo Nordisk Inc. P.O. Box 846 Plainsboro, NJ 08536 |
| Contact | Elizabeth D'amato |
| Correspondent | Elizabeth D'amato Novo Nordisk Inc. P.O. Box 846 Plainsboro, NJ 08536 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-09-19 |
| Decision Date | 2016-10-18 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30301691854592 | K162602 | 000 |
Trademark Results [NovoPen Echo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOVOPEN ECHO 79068711 3757800 Live/Registered |
Novo Nordisk A/S 2008-12-12 |
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