Catalog Number

812210-000

Brand Name

SleepmateSnore Sensor - 60 cm wire

Version/Model Number

812210-000

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

K941759,K941759

Product Code

BZQ

Product Code Name

Monitor, breathing frequency

Public Device Record Key

d0713d58-0d58-4555-8516-ae51e7d71f68

Public Version Date

October 26, 2018

Public Version Number

2

DI Record Publish Date

July 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-