VOLUSON - VOLUSON SWIFT+ CONSOLE ASSY - GE Ultrasound Korea Ltd.

Duns Number:690168810

Device Description: VOLUSON SWIFT+ CONSOLE ASSY

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More Product Details

Catalog Number

-

Brand Name

VOLUSON

Version/Model Number

SWIFT+

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K201828

Product Code Details

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Device Record Status

Public Device Record Key

4851b7cd-ed39-4d85-914c-746fb0647d8b

Public Version Date

August 16, 2022

Public Version Number

2

DI Record Publish Date

October 28, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GE ULTRASOUND KOREA LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 75