Vemp Monitor - Vemp Monitor - Gn Otometrics A/S

Duns Number:306633756

Device Description: Vemp Monitor

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More Product Details

Catalog Number

-

Brand Name

Vemp Monitor

Version/Model Number

8-36-00500

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083399

Product Code Details

Product Code

GWJ

Product Code Name

Stimulator, Auditory, Evoked Response

Device Record Status

Public Device Record Key

bf3a1fd8-536d-40b3-8e3b-cf238b7de9fb

Public Version Date

March 05, 2021

Public Version Number

1

DI Record Publish Date

February 25, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GN OTOMETRICS A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 32
2 A medical device with a moderate to high risk that requires special controls. 398