K020479 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on March 26, 2002, 41 days after receiving the submission on February 13, 2002.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K020479 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2002 |
| Decision Date | March 26, 2002 |
| Days to Decision | 41 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |