Catalog Number

1068717

Brand Name

Alice 6

Version/Model Number

Alice 6 LDxN Headbox, INTL and Brazil

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K040595

Product Code

OLV

Product Code Name

Standard polysomnograph with electroencephalograph

Public Device Record Key

c0d60c31-7cf7-4383-bce9-515f304ef5a6

Public Version Date

February 22, 2021

Public Version Number

4

DI Record Publish Date

June 27, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-