The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Datex-ohmeda S/5 Bis Module, E-bis And Accessories.
| Device ID | K052145 |
| 510k Number | K052145 |
| Device Name: | DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES |
| Classification | Index-generating Electroencephalograph Software |
| 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 | OLW |
| Subsequent Product Code | MHX |
| Subsequent Product Code | MLD |
| Subsequent Product Code | OMC |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-08 |
| Decision Date | 2005-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682104005 | K052145 | 000 |