Catalog Number

P1457850

Brand Name

Baha® Fitting Software 5

Version/Model Number

P1457850

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K161123

Product Code

LXB

Product Code Name

Hearing aid, bone conduction

Public Device Record Key

96b2dc53-4e92-4cee-a104-b0a37e69a616

Public Version Date

September 14, 2021

Public Version Number

3

DI Record Publish Date

October 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-