Catalog Number

800704-003

Brand Name

MGC Diagnostics

Version/Model Number

762042-003

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

K871711,K871711

Product Code

BZC

Product Code Name

Calculator, Pulmonary Function Data

Public Device Record Key

909c4a5f-9ced-4c94-80bc-029645a2b8c6

Public Version Date

March 08, 2022

Public Version Number

6

DI Record Publish Date

January 12, 2017

Package DI Number

800704003

Quantity per Package

1

Contains DI Package

B3687620420030

Package Discontinue Date

February 22, 2019

Package Status

Not in Commercial Distribution

Package Type

BOX