Catalog Number

39500-NP-TE

Brand Name

Welch Allyn, Inc.

Version/Model Number

901031

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180287

Product Code

EWO

Product Code Name

AUDIOMETER

Public Device Record Key

eb6d11f3-c933-4bad-b1e2-979db0ccc0a8

Public Version Date

September 05, 2019

Public Version Number

1

DI Record Publish Date

August 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-