Name: Predicase
Price: 199 USD

K-number	K230702
Device name	Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
Applicant	Qingdao Kingon Medical Science and Technology Co., Ltd.
Product code	CAW
Device class	Class II
Decision date	Oct 18, 2023
Decision	Substantially Equivalent
Regulation	868.5440

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Source

View the full FDA submission: accessdata.fda.gov

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Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)

Everything you need for a 510(k) submission. Nothing you don't.