K131968 is an FDA 510(k) clearance for the LONGFIAN OXYGEN CONCENTRATOR. This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Longfian Scitech Co., Ltd. (Miami, US). The FDA issued a Cleared decision on September 5, 2014, 434 days after receiving the submission on June 28, 2013.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K131968 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2013 |
| Decision Date | September 05, 2014 |
| Days to Decision | 434 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 |