TruScan Neurofeedback 24ch - 24 channel neurofeedback device - DEYMED Diagnostic s.r.o.

Duns Number:495566056

Device Description: 24 channel neurofeedback device

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More Product Details

Catalog Number

TS-24NFB

Brand Name

TruScan Neurofeedback 24ch

Version/Model Number

TS-24NFB

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

HCC

Product Code Name

Device, Biofeedback

Device Record Status

Public Device Record Key

3dcb414d-a001-4890-b8fe-8ee3d8f12165

Public Version Date

July 26, 2019

Public Version Number

1

DI Record Publish Date

July 18, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEYMED DIAGNOSTIC S.R.O." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3