Catalog Number

-

Brand Name

Voluson

Version/Model Number

E BT19 to BT20 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

K181985

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

40fd0ce6-5e9e-4d93-8bee-91a3ab7111b8

Public Version Date

August 20, 2019

Public Version Number

1

DI Record Publish Date

August 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-