The following data is part of a premarket notification filed by Longfian Scitech Co., Ltd. with the FDA for Oxygen Concentrator, Model Jay-5aw.
| Device ID | K213210 |
| 510k Number | K213210 |
| Device Name: | Oxygen Concentrator, Model JAY-5AW |
| Classification | Generator, Oxygen, Portable |
| Applicant | LONGFIAN SCITECH CO., LTD. 2F&3F, East Section, Building 12, Power Valley Pioneer Park, No. 369 Huiyang St. Baoding, CN 071051 |
| Contact | Shi Lei |
| Correspondent | Jun Peng P&L Scientific, Inc. 1430 S. Dixie Hwy Suite 105 Coral Gables, FL 33146 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2022-12-08 |