Catalog Number

-

Brand Name

ADVANCED DOPPLER

Version/Model Number

TD-5000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 15, 2028

Issuing Agency

In HIBCC

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

K112529

Product Code

KNG

Product Code Name

Monitor, Ultrasonic, Fetal

Public Device Record Key

9e86b723-f3ac-48d9-b9c0-b2bc33e7ab87

Public Version Date

April 27, 2020

Public Version Number

1

DI Record Publish Date

April 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-