YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B
FDA 510(k) clearance K083559 · decided 2009-09-04
Clearance details
- K-number
- K083559
- Device name
- YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-02
- Decision date
- 2009-09-04
- Days to decision
- 276 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Potomac, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.