NeXus-10 MKII - The NeXus-10 MKII is designed for medical use, - Mind Media B.V.

Duns Number:489837775

Device Description: The NeXus-10 MKII is designed for medical use, not restricted to a specific medical indica The NeXus-10 MKII is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG). The product is intended to be used by medical/acces professionals in a laboratory setup or medical office, or to be set-up in such an environment after which the subject/patient can be sent out while signal acquisition continues on memory. The NeXus 10 MKII is not intended for use in diagnosis, nor in critical and/or life supporting applications.The NeXus 10 MKII is intended for use on humans.The NeXus 10 MKII is intended to be used with approved NeXus 10 MKII accessories only. Specifically, (active) sensors intended to measure specific physiological signals, shall be designed in accordance with the specifications of the NeXus-10 MKII and may require interpretation by user or application software.

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More Product Details

Catalog Number

-

Brand Name

NeXus-10 MKII

Version/Model Number

1.2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Product Code Details

Product Code

HCC

Product Code Name

Device, Biofeedback

Device Record Status

Public Device Record Key

6c28a146-c34d-45df-a717-415a08e72c63

Public Version Date

August 23, 2021

Public Version Number

1

DI Record Publish Date

August 13, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MIND MEDIA B.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10