Otoport Binaural ABR Module (Upgrade) - Binaural ABR module for use with existing - OTODYNAMICS LIMITED

Duns Number:235908050

Device Description: Binaural ABR module for use with existing Otoport/Otocheck to add ABR functionality in add Binaural ABR module for use with existing Otoport/Otocheck to add ABR functionality in addition to OAE.

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More Product Details

Catalog Number

-

Brand Name

Otoport Binaural ABR Module (Upgrade)

Version/Model Number

ABR-UG-BI

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

K143395

Product Code Details

Product Code

EWO

Product Code Name

Audiometer

Device Record Status

Public Device Record Key

2048e79d-7ead-4e7d-b784-51c75ebe3af8

Public Version Date

November 04, 2019

Public Version Number

1

DI Record Publish Date

October 25, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OTODYNAMICS LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 116