The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Datex-ohmeda 3800+/3800p+ Or 3900/3900p Pulse Oximeters.
| Device ID | K983684 |
| 510k Number | K983684 |
| Device Name: | DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS |
| Classification | Oximeter |
| Applicant | DATEX-OHMEDA, INC. 1315 WEST CENTURY DR. Louisville, CO 80027 |
| Contact | Tom Kroenke |
| Correspondent | Tom Kroenke DATEX-OHMEDA, INC. 1315 WEST CENTURY DR. Louisville, CO 80027 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-20 |
| Decision Date | 1998-11-06 |
| Summary: | summary |