The following data is part of a premarket notification filed by Dosisoft with the FDA for Mu2net.
| Device ID | K191944 |
| 510k Number | K191944 |
| Device Name: | MU2net |
| Classification | Accelerator, Linear, Medical |
| Applicant | DOSIsoft 45/47, Avenue Carnot Cachan, FR 94230 |
| Contact | Marc Usynski |
| Correspondent | Luc Diot DOSIsoft 45/47, Avenue Carnot Cachan, FR 94230 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-22 |
| Decision Date | 2019-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B501MU2NET020101 | K191944 | 000 |