Catalog Number

-

Brand Name

Zmachine

Version/Model Number

Insight/Insight+

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K142825

Product Code

OLV

Product Code Name

Standard Polysomnograph With Electroencephalograph

Public Device Record Key

0715c2ac-a894-4904-b57d-bd597a2598e4

Public Version Date

January 28, 2019

Public Version Number

1

DI Record Publish Date

December 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-