waveguard - eeg cap accessories - eemagine Medical Imaging Solutions GmbH

Duns Number:313152485

Device Description: eeg cap accessories

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More Product Details

Catalog Number

-

Brand Name

waveguard

Version/Model Number

XE-383

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

K110223

Product Code Details

Product Code

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Device Record Status

Public Device Record Key

2a170a15-03f7-4ae0-9d0b-95a6e7595327

Public Version Date

August 21, 2020

Public Version Number

1

DI Record Publish Date

August 13, 2020

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