Catalog Number

-

Brand Name

Etymotic Research

Version/Model Number

ER3-21-BR

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K930003

Product Code

EWO

Product Code Name

Audiometer

Public Device Record Key

0db0303f-780b-4a54-a9d3-c26c3d8afe85

Public Version Date

February 03, 2022

Public Version Number

1

DI Record Publish Date

January 26, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-