The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Datex-ohmeda Trusat Pulse Oximeter And Accessories, Model 3500.
| Device ID | K040831 |
| 510k Number | K040831 |
| Device Name: | DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 |
| Classification | Oximeter, Ear |
| Applicant | DATEX-OHMEDA, INC. 1315 WEST CENTURY DR. Louisville, CO 80027 |
| Contact | Scott Light |
| Correspondent | Scott Light DATEX-OHMEDA, INC. 1315 WEST CENTURY DR. Louisville, CO 80027 |
| Product Code | DPZ |
| CFR Regulation Number | 870.2710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-31 |
| Decision Date | 2004-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682103374 | K040831 | 000 |
| 00840682103183 | K040831 | 000 |
| 00840682116749 | K040831 | 000 |
| 00840682103145 | K040831 | 000 |
| 00840682103121 | K040831 | 000 |
| 00840682103114 | K040831 | 000 |
| 00840682147316 | K040831 | 000 |
| 00840682147309 | K040831 | 000 |
| 00840682147293 | K040831 | 000 |
| 00840682147286 | K040831 | 000 |
| 00840682147279 | K040831 | 000 |
| 00840682147262 | K040831 | 000 |
| 00840682147255 | K040831 | 000 |
| 00840682103206 | K040831 | 000 |
| 00840682103213 | K040831 | 000 |
| 00840682103305 | K040831 | 000 |
| 00840682103268 | K040831 | 000 |
| 00840682103718 | K040831 | 000 |
| 00840682103398 | K040831 | 000 |
| 00840682103350 | K040831 | 000 |
| 00840682103312 | K040831 | 000 |
| 00840682116695 | K040831 | 000 |
| 00840682103282 | K040831 | 000 |
| 00840682116725 | K040831 | 000 |
| 00840682103251 | K040831 | 000 |
| 00840682103244 | K040831 | 000 |
| 00840682116770 | K040831 | 000 |
| 00840682147248 | K040831 | 000 |