AU5, AU6 by BIOSOUND ESAOTE, INC. | FDA 510(k) Summary

FDA 510(k) Search

K Number

Validate with FDA (Live)

Device Name

Manufacturer

BIOSOUND ESAOTE, INC.

Date Cleared

2000-05-03

(65 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K050551,K060800,K092182,K132466

Intended Use

Device Description

AI/ML Overview

Summary

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Regulation Number and Section

N/A