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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

MIZAR, BASIS BE, SANDMAN DIGITAL

Manufacturer

EB NEURO, S.P.A.

Date Cleared

2001-01-05

(87 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K031202,K040113,K041198,K053606,K071230

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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