510(k) K123766 ยท FMF Syringe, Piston
NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
| Applicant | Novo Nordisk, Inc., Plainsboro NJ, US |
| Decision | Substantially Equivalent, Aug 15, 2013 |
| Received | Dec 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123766
| 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.