Device Description : Bronchial Challenge Kit, Disposable (single patient use).
Device Class : 1
Duns Number: 184817096
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : KoKo Sx 1000 spirometer and software package. The Standalone Edition is configur KoKo Sx 1000 spirometer and software package. The Standalone Edition is configured to operate on a single computer without access to an Iris central database.
Device Class : 2
Duns Number: 184817096
Premarket Exempt : No
Prescription Use : Yes
Device Description : KoKo Sx 1000 spirometer and software package, fully compatible with Iris server KoKo Sx 1000 spirometer and software package, fully compatible with Iris server to allow support for networked data access, patient questionnaires, workflow, and HL7 connectivity.
Device Class : 2
Duns Number: 184817096
Premarket Exempt : No
Prescription Use : Yes
Device Description : KoKo Legend II Spirometer (with printer)
Device Class : 2
Duns Number: 184817096
Premarket Exempt : No
Prescription Use : Yes
Device Description : KoKo Legend II Spirometer (without printer)
Device Class : 2
Duns Number: 184817096
Premarket Exempt : No
Prescription Use : Yes
Device Description : Spirometry and Diffusion Capacity Pulmonary Function Testing System. Performs pr Spirometry and Diffusion Capacity 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, and optional Maximum Pressures (MIP/MEP) tests.
Device Class : 2
Duns Number: 184817096
Premarket Exempt : No
Prescription Use : Yes
Device Description : Spirometry, Diffusion Capacity, and Nitrogen Washout Lung Volumes Pulmonary Func Spirometry, Diffusion Capacity, and Nitrogen Washout Lung Volumes 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, Multiple Breath Nitrogen Washout Lung Volumes, Maldistribution of Ventilation, Delta N2 & Closing Volume, and optional Maximum Pressures (MIP/MEP) tests.
Device Class : 2
Duns Number: 184817096
Premarket Exempt : No
Prescription Use : Yes
Device Description : Spirometry, Diffusion Capacity, and Plethysmography Pulmonary Function Testing S 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.
Device Class : 2
Duns Number: 184817096
Premarket Exempt : No
Prescription Use : Yes
Device Description : All-digital, tempered glass and metal body plethysmograph features fail-safe aut All-digital, tempered glass and metal body plethysmograph features fail-safe automatic release of the cabin door locking mechanism, patient intercom, and motorized sensor arm, providing superior performance, patient comfort and convenience.
Device Class : 2
Duns Number: 184817096
Premarket Exempt : No
Prescription Use : Yes
Device Description : All-digital, tempered glass and metal body plethysmograph features fail-safe aut All-digital, tempered glass and metal body plethysmograph features fail-safe automatic release of the cabin door locking mechanism, patient intercom, and motorized sensor arm, providing superior performance, patient comfort and convenience.
Device Class : 2
Duns Number: 184817096
Premarket Exempt : No
Prescription Use : Yes