K-number	K222511
Device name	Oxy2Pro
Applicant	Southmedic, Inc.
Product code	CCK
Device class	Class II
Decision date	Nov 21, 2023
Decision	Substantially Equivalent
Regulation	868.1400

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Source

View the full FDA submission: accessdata.fda.gov

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Oxy2Pro

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