KoKo, LLC PX3000

GUDID 00852417003491

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.

Koko, LLC

Pulmonary function analysis system, adult
Primary Device ID00852417003491
NIH Device Record Keyd1e817b6-7956-4b8c-805d-996b5ef43278
Commercial Distribution StatusIn Commercial Distribution
Brand NameKoKo, LLC
Version Model NumberKoKo Px 3000 Pulmonary Function Testing System
Catalog NumberPX3000
Company DUNS117528917
Company NameKoko, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100852417003491 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZGSpirometer, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-14
Device Publish Date2020-12-05

On-Brand Devices [KoKo, LLC]

00852417003491Spirometry, Diffusion Capacity, and Nitrogen Washout Lung Volumes Pulmonary Function Testing Sys
00852417003514All-digital, tempered glass and metal body plethysmograph features fail-safe automatic release o
00852417003507Spirometry, Diffusion Capacity, Nitrogen Washout Lung Volumes and Plethysmography Pulmonary Func

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.