Catalog Number

911080GB

Brand Name

MIR

Version/Model Number

Spirolab New spirometer Light Bluetooth

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K061875

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

b360a3e5-1395-4c61-9db9-efae37e6d18c

Public Version Date

March 08, 2022

Public Version Number

5

DI Record Publish Date

February 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-