Catalog Number

360-8400

Brand Name

OmniPro System

Version/Model Number

OmniAmp PSG Module

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

K050143

Product Code

OLV

Product Code Name

Standard Polysomnograph With Electroencephalograph

Public Device Record Key

6891bc5b-7328-4f28-aeb5-15623378ea93

Public Version Date

December 17, 2019

Public Version Number

1

DI Record Publish Date

December 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-