Catalog Number

-

Brand Name

Lifelines Photic Stimulator

Version/Model Number

Photic Stimulator Kit

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

K101691

Product Code

GWE

Product Code Name

Stimulator, Photic, Evoked Response

Public Device Record Key

379fffdd-7cc1-4220-b2af-a2ffb70004f3

Public Version Date

July 12, 2019

Public Version Number

1

DI Record Publish Date

July 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-