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510(k) Data Aggregation

K Number

Device Name

Edema Guard Monitor (EGM) CardioSet-001

Manufacturer

CardioSet Medical Ltd.

Date Cleared

2025-09-09

(166 days)

Product Code

Regulation Number

Type

Panel

Cardiovascular (CV)

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

CardioSet Medical Ltd.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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