KoKo - Wright Haloscale Respirometer
2023-08-01
KoKo PFT LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006254047 | 3006254047 | KoKo PFT LTD. | 1 | N | 2026-01-01 | 112D Brooker Road Waltham Abbey Essex GB EN9 1JH |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 26004 | 1287624876 | K934475 | KOKO FILTER II | CAH | 1993-10-21 |
| 26004 | 1775384949 | K914272 | KOKO SPIROMETER | BZG | 1992-07-02 |
| 26004 | 1375449314 | K091853 | WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 | BZK | 2009-09-21 |
| 26004 | 1313392167 | K052328 | ZAN LUNG-FUNCTION LAB | BZC | 2005-12-22 |
| 26004 | 1603515922 | K052176 | FLOWHANDY ZAN100 USB | BZG | 2006-01-12 |
| 26004 | 1652746096 | K030917 | GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130 | BZG | 2003-05-14 |
Product Codes Associated With Registrations#
GUDID#
KoKo - Wright Respirometer Mk 14
2023-08-01
KoKo - Wright Respirometer Mk 8
2023-08-01
KoKo, LLC - 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.
2021-04-16
KoKo, LLC - 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.
2021-04-16
KoKo, LLC - 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.
2020-12-05