Catalog Number

-

Brand Name

Doppler Fetal Heart Rate Detector

Version/Model Number

FM-200

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K100626,K100626

Product Code

KNG

Product Code Name

Monitor, Ultrasonic, Fetal

Public Device Record Key

aa8befc6-5609-4e5f-a5ea-4f2d2f9af544

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 18, 2016

Package DI Number

06937683490009

Quantity per Package

1

Contains DI Package

06937683443128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-