K172234 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 Sysmed (China) Co., Ltd. (Shenyang, CN). The FDA issued a Cleared decision on June 1, 2018, 311 days after receiving the submission on July 25, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K172234 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2017 |
| Decision Date | June 01, 2018 |
| Days to Decision | 311 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 |