The following data is part of a premarket notification filed by Foshan Mic Medical Technology Co., Ltd with the FDA for Oxygen Concentrator.
| Device ID | K202389 |
| 510k Number | K202389 |
| Device Name: | Oxygen Concentrator |
| Classification | Generator, Oxygen, Portable |
| Applicant | Foshan MIC Medical Technology Co., LTD U501-1,503, 5F, No.7 Building, Zone A Hantian Industrial Park 17th Shenhai R Foshan, CN 528200 |
| Contact | Wu Huahong |
| Correspondent | Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, CN 510000 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-21 |
| Decision Date | 2022-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970379850299 | K202389 | 000 |
| 00860012953318 | K202389 | 000 |
| 00860012953325 | K202389 | 000 |
| 00860012953332 | K202389 | 000 |
| 00860012953349 | K202389 | 000 |
| 06970379850251 | K202389 | 000 |
| 06970379850268 | K202389 | 000 |
| 06970379850275 | K202389 | 000 |
| 06970379850282 | K202389 | 000 |
| 00860012953301 | K202389 | 000 |