The following data is part of a premarket notification filed by Ge Healthcare Filand Oy with the FDA for Entropy Module, E-entropy-01.
| Device ID | K150298 |
| 510k Number | K150298 |
| Device Name: | Entropy Module, E-ENTROPY-01 |
| Classification | Index-generating Electroencephalograph Software |
| Applicant | GE HEALTHCARE FILAND OY KUORTANEENKATU 2 Helsinki, FI 00510 |
| Contact | Joel Kent |
| Correspondent | Joel Kent GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Product Code | OLW |
| 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 | 2015-02-06 |
| Decision Date | 2015-11-12 |
| Summary: | summary |