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510(k) Data Aggregation

K Number

Device Name

CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH

Manufacturer

BIONET COMPANY LTD

Date Cleared

2001-11-21

(204 days)

Product Code

Regulation Number

N/A

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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