The following data is part of a premarket notification filed by Aidera Ab with the FDA for Aidera Diasend System.
| Device ID | K101806 |
| 510k Number | K101806 |
| Device Name: | AIDERA DIASEND SYSTEM |
| Classification | Accessories, Pump, Infusion |
| Applicant | AIDERA AB MEDICINAREGATAN 8A Goteborg, SE Se 413 46 |
| Contact | Anders Sonesson |
| Correspondent | Anders Sonesson AIDERA AB MEDICINAREGATAN 8A Goteborg, SE Se 413 46 |
| Product Code | MRZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-28 |
| Decision Date | 2010-12-07 |
| Summary: | summary |