eego amplifier - StimGuide component - eemagine Medical Imaging Solutions GmbH

Duns Number:313152485

Device Description: StimGuide component

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More Product Details

Catalog Number

-

Brand Name

eego amplifier

Version/Model Number

EE-410

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K183376

Product Code Details

Product Code

IKN

Product Code Name

Electromyograph, diagnostic

Device Record Status

Public Device Record Key

76ed0578-307a-409a-b443-87d3d1819bfb

Public Version Date

June 24, 2019

Public Version Number

1

DI Record Publish Date

June 14, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 183