Duns Number:184817096
Device Description: Spirometry, Diffusion Capacity, and Plethysmography Pulmonary Function Testing System. Per Spirometry, Diffusion Capacity, and Plethysmography Pulmonary Function Testing System. Performs pre/post drug Spirometry (FVC, SVC & MVV), Bronchial Challenge, Diffusing Capacity (using ATS/ERS 10-second breath-hold or 3-Equation no breath hold methods), Single Breath Lung Volumes including SVC, Maldistribution of Ventilation, Delta N2 & Closing Volume, Whole Body Plethysmograph for Lung Volumes, Airways Resistance & Conductance, and optional Maximum Pressures (MIP/MEP) tests.
Catalog Number
PX4000
Brand Name
nSpire Health
Version/Model Number
KoKo Px 4000 Pulmonary Function System
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
K030464
Product Code
BZG
Product Code Name
Spirometer, Diagnostic
Public Device Record Key
4a2b5a52-4305-4a92-b82d-70fe83309edc
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
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. | 14 |