The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for E-eegx, N-eegx.
| Device ID | K191322 |
| 510k Number | K191322 |
| Device Name: | E-EEGX, N-EEGX |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki, FI Fi-00510 |
| Contact | Joel Kent |
| Correspondent | Joel Kent GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki, FI Fi-00510 |
| Product Code | OLT |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | MHX |
| Subsequent Product Code | MLD |
| 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 | 2019-05-15 |
| Decision Date | 2020-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278466679 | K191322 | 000 |
| 00195278466662 | K191322 | 000 |