Catalog Number

815000-119

Brand Name

Body Position Sensor - Alice 3

Version/Model Number

815000-119

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 07, 2019

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"

Yes

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

K923033

Product Code

LXJ

Product Code Name

System, Optical Position/Movement Recording

Public Device Record Key

609ad262-edd5-4886-8602-6087cc593eb8

Public Version Date

February 07, 2019

Public Version Number

1

DI Record Publish Date

January 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-