Catalog Number

VOLUSON-P8-BT22

Brand Name

Voluson

Version/Model Number

P8 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

K180535,K213689

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

bfde76fd-1cd8-4e57-9d57-ff3cf4e5c212

Public Version Date

February 24, 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

-