Name: Predicase
Price: 199 USD

K-number	K251607
Device name	Oxygen Concentrator (J5A)
Applicant	Foshan Kycare Medical Equipment Co., Ltd.
Product code	CAW
Device class	Class II
Decision date	Nov 21, 2025
Decision	Substantially Equivalent
Regulation	868.5440

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Oxygen Concentrator (J5A)

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