Catalog Number

NA – MOUNT1

Brand Name

Temporal Monitoring Headset

Version/Model Number

40-00010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 24, 2020

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

K160442

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

b7848b60-9bd6-4640-8fec-aae5a71a517e

Public Version Date

August 22, 2022

Public Version Number

6

DI Record Publish Date

May 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-