K040831 is an FDA 510(k) clearance for the DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500. This device is classified as a Oximeter, Ear (Class II - Special Controls, product code DPZ).
Submitted by Datex-Ohmeda, Inc. (Louisville, US). The FDA issued a Cleared decision on September 2, 2004, 155 days after receiving the submission on March 31, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2710.
| 510(k) Number | K040831 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2004 |
| Decision Date | September 02, 2004 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DPZ — Oximeter, Ear |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2710 |