Catalog Number

-

Brand Name

SOYES Fetal Doppler

Version/Model Number

FD-570B

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182526,K182526

Product Code

KNG

Product Code Name

Monitor, Ultrasonic, Fetal

Public Device Record Key

b1dba713-441a-4e9f-a585-20cae19668e1

Public Version Date

May 17, 2021

Public Version Number

1

DI Record Publish Date

May 08, 2021

Package DI Number

16970442090390

Quantity per Package

30

Contains DI Package

06970442090393

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box