Catalog Number

AME-02021

Brand Name

EarlySense® InSight™

Version/Model Number

Insight at Home

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152911

Product Code

BZQ

Product Code Name

Monitor, Breathing Frequency

Public Device Record Key

cc5d00a9-6cca-46f2-993e-604e33d9c8ae

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

July 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-