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510(k) Data Aggregation

K Number

Device Name

Manufacturer

BIOSOUND ESAOTE, INC.

Date Cleared

2000-05-03

(65 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

K050551,K060800,K092182,K132466

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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