Component Neuromonitoring System - International (non-U.S.) model; a portable, - MOBERG RESEARCH INC

Duns Number:029957656

Device Description: International (non-U.S.) model; a portable, computer-based system that can continuously re International (non-U.S.) model; a portable, computer-based system that can continuously record, display, store and analyze physiological data from multiple monitoring sources in real time.

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More Product Details

Catalog Number

-

Brand Name

Component Neuromonitoring System

Version/Model Number

CNS-320

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K080217

Product Code Details

Product Code

GWQ

Product Code Name

Full-Montage Standard Electroencephalograph

Device Record Status

Public Device Record Key

fae4cdb5-d533-4b38-b011-47094d547578

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 21, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MOBERG RESEARCH INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22