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510(k) Data Aggregation

K Number

Device Name

Mendaera Guidance System

Manufacturer

Mendaera, Inc.

Date Cleared

2025-07-02

(131 days)

Product Code

ITX

Regulation Number

892.1570

Why did this record match?

Applicant Name (Manufacturer) :

Mendaera, Inc.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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