Catalog Number

-

Brand Name

Etymotic Research

Version/Model Number

ER3-28S

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

Yes

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

K873298

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

195ac322-d1fc-4d4b-bf1a-891376425a18

Public Version Date

January 14, 2019

Public Version Number

1

DI Record Publish Date

December 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-