K210371 is an FDA 510(k) clearance for the Portable Oxygen Concentrator, model: P2-E6. This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Qingdao Kingon Medical Science and Technology Co., Ltd. (Qingdao Free Trade Zone, CN). The FDA issued a Cleared decision on June 3, 2022, 480 days after receiving the submission on February 8, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K210371 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2021 |
| Decision Date | June 03, 2022 |
| Days to Decision | 480 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 |