Catalog Number

-

Brand Name

Etymotic Research

Version/Model Number

ER7-14C-EM

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 11, 2016

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K861113

Product Code

ETW

Product Code Name

Calibrator, Hearing Aid / Earphone And Analysis Systems

Public Device Record Key

bb070c51-fc9a-4f72-8964-544e5d4f806b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-