K042891 is an FDA 510(k) clearance for the DATEX-OHMEDA OXY-AFR SENSOR. This device is classified as a Oximeter, Reprocessed (Class II - Special Controls, product code NLF).
Submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on June 29, 2005, 253 days after receiving the submission on October 19, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700. Same As Dqa Except Reprocessed. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf)..
| 510(k) Number | K042891 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2004 |
| Decision Date | June 29, 2005 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NLF — Oximeter, Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |
| Definition | Same As Dqa Except Reprocessed. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf). |