Koko, LLC

Address:1200 S Fordham,Longmont,CO,80503,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Spirometer, Diagnostic (BZG) (2) Plethysmograph, Pressure (CCM) (1)

Premarket Exempt

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KoKo, LLC - 00852417003491 Catalog Number : PX3000

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, Diffusion 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: 117528917

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

KoKo, LLC - 00852417003507 Catalog Number : PX4000N

Device Description : Spirometry, Diffusion Capacity, Nitrogen Washout Lung Volumes and Plethysmograph Spirometry, Diffusion Capacity, Nitrogen Washout Lung Volumes 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, Multiple Breath Nitrogen Washout Lung Volumes, 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: 117528917

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

KoKo, LLC - 00852417003514 Catalog Number : 700971

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 convienence.

Device Class : 2

Duns Number: 117528917

Premarket Exempt : No

Product Code : CCM

Prescription Use : Yes

Device Count : 1

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