Catalog Number

-

Brand Name

GN Otometrics A/S

Version/Model Number

OTOair 2 Bluetooth Dongle

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

K110286

Product Code

ETW

Product Code Name

Calibrator, Hearing Aid / Earphone And Analysis Systems

Public Device Record Key

0711c771-1716-45a5-a125-8cc1cff4485d

Public Version Date

December 03, 2020

Public Version Number

3

DI Record Publish Date

March 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-