The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Datex-ohmeda S/5 Bis Module, M-bis And Accessories.
| Device ID | K013389 |
| 510k Number | K013389 |
| Device Name: | DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES |
| Classification | Index-generating Electroencephalograph Software |
| Applicant | DATEX-OHMEDA 86 PILGRIM RD. Needham, MA 02492 |
| Contact | Joel Kent |
| Correspondent | Joel Kent DATEX-OHMEDA 86 PILGRIM RD. 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 | 2001-10-12 |
| Decision Date | 2002-01-10 |
| Summary: | summary |