Yuyue Oxygenmax Oxygen Concentrator, Models: 7F-5A/7F-5B
FDA 510(k) K083559 · Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
510(k) numberK083559
Submission
- Device name
- Yuyue Oxygenmax Oxygen Concentrator, Models: 7F-5A/7F-5B
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Potomac, MD, US - Received
- December 2, 2008
- Decision date
- September 4, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAW – Generator, Oxygen, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5440
- Specialty
- Anesthesiology
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| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555)CAW · Traditional | Devilbiss Healthcare, LLC | 03/26/2026SE |
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| K252616 | Portable oxygen concentrator (JLO-190P)CAW · Traditional | Shenzhen Homed Medical Device Co., Ltd. | 12/22/2025SE |
| K251764 | Oxygen Concentrator-P2-O5ECAW · Traditional | Qingdao Kingon Medical Science and Technology… | 12/22/2025SE |
| K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C)CAW · Traditional | Shenzhen Harveymed Technology Co., Ltd. | 12/16/2025SE |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)CAW · Traditional | Devilbiss Healthcare, LLC | 12/09/2025SE |
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Questions and answers
When was Yuyue Oxygenmax Oxygen Concentrator, Models: 7F-5A/7F-5B cleared by the FDA?
Yuyue Oxygenmax Oxygen Concentrator, Models: 7F-5A/7F-5B (K083559) received a 510(k) decision of Substantially Equivalent on September 4, 2009, 276 days after the submission was received.
What is the product code of K083559?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.