Catalog Number

-

Brand Name

830 to 860 Upgrade

Version/Model Number

H3908AM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173816

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

42dc7d82-ed41-45c6-a7a5-bff4bba9e26d

Public Version Date

February 04, 2020

Public Version Number

2

DI Record Publish Date

May 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-