Catalog Number

36-SPC1000-STK

Brand Name

Spirometry PC Software

Version/Model Number

2.5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 27, 2019

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

K141936

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

e0cc304c-d2a9-4db0-8a9f-ae46335f14c5

Public Version Date

May 28, 2019

Public Version Number

4

DI Record Publish Date

October 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-