Catalog Number

8012-0008-05

Brand Name

Compumedics Somte

Version/Model Number

Somte

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

K021176

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

fd2bec26-5587-4fb7-b1ee-e5ec035a8958

Public Version Date

April 27, 2021

Public Version Number

4

DI Record Publish Date

November 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-