K213210 is an FDA 510(k) clearance for the Oxygen Concentrator, Model JAY-5AW. This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Longfian Scitech Co., Ltd. (Baoding, CN). The FDA issued a Cleared decision on December 8, 2022, 435 days after receiving the submission on September 29, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K213210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2021 |
| Decision Date | December 08, 2022 |
| Days to Decision | 435 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 |