The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Datex-ohmeda Oxygen Saturation Module, M-osat And Accessoires.
| Device ID | K010463 |
| 510k Number | K010463 |
| Device Name: | DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES |
| Classification | Oximeter |
| Applicant | DATEX-OHMEDA, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent DATEX-OHMEDA, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-16 |
| Decision Date | 2001-03-15 |