The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Ge Entropy Sensor (refm1038681) And Ge Entropy Cable (ref M1050784).
| Device ID | K062580 |
| 510k Number | K062580 |
| Device Name: | GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) |
| Classification | Electrode, Cutaneous |
| 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 | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-31 |
| Decision Date | 2007-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682102964 | K062580 | 000 |