Catalog Number

-

Brand Name

BE Micro Recorder

Version/Model Number

B9700073000

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

K093728

Product Code

GWL

Product Code Name

Amplifier, Physiological Signal

Public Device Record Key

d198e2c2-4906-49a0-a75a-9f49173adb8c

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

April 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-