Catalog Number

-

Brand Name

Voluson

Version/Model Number

E BT18 to BT19 UPG

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

K172342

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

f0152d72-091e-421f-a05a-434411e831d0

Public Version Date

September 17, 2018

Public Version Number

1

DI Record Publish Date

August 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-