The following data is part of a premarket notification filed by Zhongshan A&j Medical Equipment Co., Ltd. with the FDA for A&j Poca01 Oxygen Concentrator.
| Device ID | K071608 |
| 510k Number | K071608 |
| Device Name: | A&J POCA01 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 | Polo Chen |
| Correspondent | Michelle S Lee UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-06-12 |
| Decision Date | 2008-01-11 |
| Summary: | summary |