K202389 is an FDA 510(k) clearance for the Oxygen Concentrator. This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Foshan Mic Medical Technology Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on April 8, 2022, 595 days after receiving the submission on August 21, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K202389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2020 |
| Decision Date | April 08, 2022 |
| Days to Decision | 595 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CAW - Generator, Oxygen, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5440 |