The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Datex-ohmeda Tuffsat 3000 Pulse Oximeter.
| Device ID | K001688 |
| 510k Number | K001688 |
| Device Name: | DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | DATEX-OHMEDA, INC. 1315 WEST CENTURY DR. Louisville, CO 80027 |
| Contact | Dale Thanig |
| Correspondent | Dale Thanig 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 | 2000-06-02 |
| Decision Date | 2000-06-30 |