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510(k) Data Aggregation

K Number

Device Name

Manufacturer

GENERAL ELECTRIC CO.

Date Cleared

2001-03-01

(27 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

K014097,K032182,K041813,K042369,K052042,K052441,K073408

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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