The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Entropy Easyfit Sensor.
| Device ID | K103129 |
| 510k Number | K103129 |
| Device Name: | ENTROPY EASYFIT SENSOR |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Contact | Joel Kent |
| Correspondent | Joel Kent GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-22 |
| Decision Date | 2011-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20840682102975 | K103129 | 000 |