Catalog Number

340-22601

Brand Name

Fetal Monitor Remote Display

Version/Model Number

FMRD 4K 55"

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K931133

Product Code

HGM

Product Code Name

System, Monitoring, Perinatal

Public Device Record Key

0a101920-7296-45cd-a412-25a3b2f59895

Public Version Date

May 19, 2020

Public Version Number

2

DI Record Publish Date

November 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-