Catalog Number

-

Brand Name

MGC Diagnostics

Version/Model Number

800830-021

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 22, 2019

Issuing Agency

In HIBCC

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

K061731

Product Code

BZL

Product Code Name

Computer, Oxygen-Uptake

Public Device Record Key

24dab8b6-2396-49e2-8daf-1a6eafa570ba

Public Version Date

August 10, 2021

Public Version Number

2

DI Record Publish Date

June 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-