Catalog Number

815600-100

Brand Name

SleepmateAC Body Position Sensor Kit

Version/Model Number

815600-100

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"

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

3ebaf73f-65d0-4053-9d1a-a68d673b6b76

Public Version Date

July 15, 2019

Public Version Number

2

DI Record Publish Date

January 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-