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510(k) Data Aggregation

K Number

Device Name

Oxiplex®

Manufacturer

FzioMed, Inc.

Date Cleared

2025-06-17

(330 days)

Product Code

QVL

Regulation Number

888.3047

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Product Code :

QVL

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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