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510(k) Data Aggregation

K Number

Device Name

SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A

Manufacturer

ST. JUDE MEDICAL

Date Cleared

2010-09-15

(65 days)

Product Code

Regulation Number

Type

Panel

Cardiovascular (CV)

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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