Duns Number:341625331
Device Description: Diagnostic spirometer for measurement and data collection of lung function parameters
Catalog Number
-
Brand Name
SpiroSphere
Version/Model Number
SpiroSphere Standard
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
K173937
Product Code
BTY
Product Code Name
Calculator, Predicted Values, Pulmonary Function
Public Device Record Key
03fceb9c-861b-4f74-a2ab-08568cf6f71c
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
February 18, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |