The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Ge Entropy Sensor.
| Device ID | K082540 |
| 510k Number | K082540 |
| Device Name: | GE ENTROPY SENSOR |
| Classification | Electrode, Cutaneous |
| Applicant | GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-02 |
| Decision Date | 2008-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20840682102951 | K082540 | 000 |