The following data is part of a premarket notification filed by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. with the FDA for Yuyue Oxygenmax Oxygen Concentrator, Models: 7f-5a/7f-5b.
| Device ID | K083559 |
| 510k Number | K083559 |
| Device Name: | YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B |
| Classification | Generator, Oxygen, Portable |
| Applicant | JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Contact | Norman F Estrin |
| Correspondent | Norman F Estrin JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-02 |
| Decision Date | 2009-09-04 |
| Summary: | summary |