K-number	DEN240038
Device name	Oxiplex®
Applicant	Fziomed, Inc.
Product code	QVL
Device class	Class II
Decision date	Jun 17, 2025
Decision	Not Substantially Equivalent
Regulation	888.3047

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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Oxiplex®

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