The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Modification To: Datex-ohmeda S/5 Entropy Module, E-entropy And Accessories.
| Device ID | K061907 |
| 510k Number | K061907 |
| Device Name: | MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES |
| Classification | Index-generating Electroencephalograph Software |
| 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 | 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 | 2006-07-05 |
| Decision Date | 2008-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682104272 | K061907 | 000 |