K040892 is an FDA 510(k) clearance for the MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905. This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Nidek Medical Products, Inc. (Birmingham, US). The FDA issued a Cleared decision on April 29, 2004, 23 days after receiving the submission on April 6, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K040892 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2004 |
| Decision Date | April 29, 2004 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAW - Generator, Oxygen, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5440 |