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510(k) Data Aggregation

K Number

Device Name

Manufacturer

Date Cleared

2025-06-17

(330 days)

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Type

Panel

Orthopedic (OR)

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

Oxiplex**®**

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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