The following data is part of a premarket notification filed by Zhongshan A&j Medical Equipment Co., Ltd. with the FDA for A&j 5l Poca Series Oxygen Concentrator.
| Device ID | K121531 |
| 510k Number | K121531 |
| Device Name: | A&J 5L POCA SERIES OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. 3 SHENGHUI SOUTH ROAD NANTOU TOWN, ZHONGSHAN CITY Guangdong, CN |
| Contact | Junhong An |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-05-24 |
| Decision Date | 2012-07-17 |
| Summary: | summary |