Catalog Number

TI10.03EU_01

Brand Name

Desyncra For Tinnitus Therapy System

Version/Model Number

Size L

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151558

Product Code

KLW

Product Code Name

Masker, Tinnitus

Public Device Record Key

daf4fcd5-fe99-4aca-bf1e-c87d7a64c656

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-