The following data is part of a premarket notification filed by Nilimedix Ltd. with the FDA for Nilimedix Adi.
| Device ID | K070844 |
| 510k Number | K070844 |
| Device Name: | NILIMEDIX ADI |
| Classification | Pump, Infusion, Insulin |
| Applicant | NILIMEDIX LTD. 31 HAAVODA ST. Binyamina, IL |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy NILIMEDIX LTD. 31 HAAVODA ST. Binyamina, IL |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-27 |
| Decision Date | 2008-06-06 |
| Summary: | summary |