Catalog Number

-

Brand Name

Insight Discovery EMG

Version/Model Number

900-037

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

K063447

Product Code

HCC

Product Code Name

Device, Biofeedback

Public Device Record Key

feda6b68-6e17-4662-83a7-7d98c2d1e953

Public Version Date

August 27, 2021

Public Version Number

1

DI Record Publish Date

August 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-