A Standardized Probe - Digitally programmed S-shaped amplifier - QUANTEL MEDICAL

Duns Number:738574953

Device Description: Digitally programmed S-shaped amplifier characteristics and comprehensive design criteria Digitally programmed S-shaped amplifier characteristics and comprehensive design criteria for standardized echography and tissue differentiation according to Karl C. Ossoinig MD

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More Product Details

Catalog Number

-

Brand Name

A Standardized Probe

Version/Model Number

Std-A

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

K051851

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

be65911d-7508-4d40-bb42-59b12d144ad1

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"QUANTEL MEDICAL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 55