Name: Predicase
Price: 199 USD

K-number	K213825
Device name	Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
Applicant	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Product code	CAW
Device class	Class II
Decision date	Apr 28, 2023
Decision	Substantially Equivalent
Regulation	868.5440

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Source

View the full FDA submission: accessdata.fda.gov

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Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

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