Catalog Number

-

Brand Name

Prosomnus IA with Patient Monitoring

Version/Model Number

IA Monogram Monitor

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"

-

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

K161624

Product Code

PLC

Product Code Name

Sleep Appliances With Patient Monitoring

Public Device Record Key

10c906f3-85ac-443f-b0f1-8f7f8516444c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-