K082566 is an FDA 510(k) clearance for the MARK 5 NUVO LITE OCSI AND STD. 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 December 3, 2008, 90 days after receiving the submission on September 4, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K082566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2008 |
| Decision Date | December 03, 2008 |
| Days to Decision | 90 days |
| Submission Type | Abbreviated |
| 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 |