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510(k) Data Aggregation

K Number

Device Name

STATNET, MODEL 3100

Manufacturer

HYDRODOT, INC

Date Cleared

2010-01-29

(137 days)

Product Code

GXY

Regulation Number

882.1320

Why did this record match?

Applicant Name (Manufacturer) :

HYDRODOT, INC

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

An Electroencepahlogram (EEG) electrode array intended for use in the ER, ICU and OR for recording of STAT EEGs in patients of 18 years of age and older.

Device Description

StatNet EEG Headpiece

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