The following data is part of a premarket notification filed by Austrian Institute Of Technology Gmbh with the FDA for Encevis.
| Device ID | K211452 |
| 510k Number | K211452 |
| Device Name: | Encevis |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | Austrian Institute Of Technology GmbH Giefinggasse 4 Vienna, AT 1210 |
| Contact | Tilmann Kluge |
| Correspondent | Tilmann Kluge Austrian Institute Of Technology GmbH Giefinggasse 4 Vienna, AT 1210 |
| Product Code | OMB |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OMA |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-10 |
| Decision Date | 2021-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09120109830122 | K211452 | 000 |