510(k) K162602 ยท FMF Syringe, Piston
NovoPen Echo
| Applicant | Novo Nordisk, Inc., Plainsboro NJ, US |
| Decision | Substantially Equivalent, Oct 18, 2016 |
| Received | Sep 19, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162602
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 5, 2017 | Novo Nordisk Inc Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders
Product Usage:
The NovoPen Echo is a re-usable pen injector for single patient use by diabetics for the self injection of a desire Terminated |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.