Mobile Stand - Radiological imaging system transport kit - ECHONOUS, INC.

Duns Number:080481089

Device Description: Radiological imaging system transport kit

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More Product Details

Catalog Number

-

Brand Name

Mobile Stand

Version/Model Number

P005149

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

K181574

Product Code Details

Product Code

IYO

Product Code Name

System, Imaging, Pulsed Echo, Ultrasonic

Device Record Status

Public Device Record Key

1e502222-3839-42d7-9026-2359bfa7b35b

Public Version Date

November 12, 2019

Public Version Number

2

DI Record Publish Date

August 09, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ECHONOUS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 46