The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Datex-ohmeda Oxy-afr Sensor.
| Device ID | K042891 |
| 510k Number | K042891 |
| Device Name: | DATEX-OHMEDA OXY-AFR SENSOR |
| Classification | Oximeter, Reprocessed |
| Applicant | DATEX-OHMEDA 86 PILGRIM RD. Needham, MA 02492 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent DATEX-OHMEDA 86 PILGRIM RD. Needham, MA 02492 |
| Product Code | NLF |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-19 |
| Decision Date | 2005-06-29 |
| Summary: | summary |