Catalog Number

003609-2526-313-1720

Brand Name

audifon

Version/Model Number

switch 8 TRT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2016

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K091552

Product Code

ESD

Product Code Name

Hearing Aid, Air Conduction

Public Device Record Key

a5e9b515-1d4a-409d-a731-3621bc65b9fe

Public Version Date

October 06, 2020

Public Version Number

5

DI Record Publish Date

November 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-