PulmoScan

Impedance Measuring Device Utilizing Oscillation Techniques

Cognita Labs, LLC

The following data is part of a premarket notification filed by Cognita Labs, Llc with the FDA for Pulmoscan.

Pre-market Notification Details

Device IDK191876
510k NumberK191876
Device Name:PulmoScan
ClassificationImpedance Measuring Device Utilizing Oscillation Techniques
Applicant Cognita Labs, LLC 700 N Main St. Ste C1 Santa Ana,  CA  92701
ContactRajoshi Biswas
CorrespondentRajoshi Biswas
Cognita Labs, LLC 700 N Main St. Ste C1 Santa Ana,  CA  92701
Product CodePNV  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyAnesthesiology
510k Review PanelAnesthesiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-15
Decision Date2020-03-18

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