The following data is part of a premarket notification filed by Eemagine Medical Imaging Solutions Gmbh with the FDA for Neo.
| Device ID | K192889 |
| 510k Number | K192889 |
| Device Name: | Neo |
| Classification | Amplitude-integrated Electroencephalograph |
| Applicant | eemagine Medical Imaging Solutions GmbH Gubener Str. 47 Berlin, DE D-10243 |
| Contact | Maarten Van De Velde |
| Correspondent | Steve Hesler Steve Hesler 2602 5th Avenue West Linn, OR 97068 |
| Product Code | OMA |
| Subsequent Product Code | OMC |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-10 |
| Decision Date | 2020-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B195LE800 | K192889 | 000 |
| B195ES820 | K192889 | 000 |