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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

EEG MIS MONITOR MODEL # A-2000; BIS ENGINE

Manufacturer

ASPECT MEDICAL SYSTEMS, INC.

Date Cleared

2001-06-15

(28 days)

Product Code

OLW,OLT,OMC,ORT

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K013389,K030267,K031694

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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AI/ML Overview

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