The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Datex-ohmeda S/5 Device Interfacing Solution, N-disxxxx.
| Device ID | K012531 |
| 510k Number | K012531 |
| Device Name: | DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX |
| Classification | System, Network And Communication, Physiological Monitors |
| 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 | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-06 |
| Decision Date | 2001-11-02 |
| Summary: | summary |