Catalog Number

VOLUSON-S8-BT22

Brand Name

Voluson

Version/Model Number

S8 BT22

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180374,K213642

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

64bb029c-f5a0-41bf-ad62-82dd726af35e

Public Version Date

January 27, 2022

Public Version Number

2

DI Record Publish Date

December 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-