Catalog Number

-

Brand Name

SIMZO

Version/Model Number

HW-F7

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 15, 2021

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

K173048

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

168d5fdd-693a-4c5e-ba19-9dd97852e632

Public Version Date

July 28, 2021

Public Version Number

5

DI Record Publish Date

May 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-