Catalog Number

718-7710

Brand Name

E-Scope Hearing Impaired

Version/Model Number

7187710

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K961301

Product Code

DQD

Product Code Name

Stethoscope, Electronic

Public Device Record Key

190935b9-f111-44a4-a381-bce3679cd3a1

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

April 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-