Catalog Number

FPRSA00013

Brand Name

Probe sensor assembly for MindRay

Version/Model Number

FPRSA00013

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K100784

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

b2328b05-25ee-481f-b3e2-ee7331c865d9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-