K240561 is an FDA 510(k) clearance for the Rugged Oxygen Generator (ROG) (RO01-00001). This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Molecular Products , Ltd. (Harlow Essex, GB). The FDA issued a Cleared decision on December 6, 2024, 281 days after receiving the submission on February 29, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K240561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 29, 2024 |
| Decision Date | December 06, 2024 |
| Days to Decision | 281 days |
| Submission Type | Traditional |
| 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 |