Broncholab

System, X-ray, Tomography, Computed

Fluidda Inc.

The following data is part of a premarket notification filed by Fluidda Inc. with the FDA for Broncholab.

Pre-market Notification Details

Device IDK191550
510k NumberK191550
Device Name:Broncholab
ClassificationSystem, X-ray, Tomography, Computed
Applicant Fluidda Inc. 750 N. San Vicente Blvd, Suite 800 West West Hollywood,  CA  90069
ContactAnjali Nair
CorrespondentAnjali Nair
Fluidda Inc. 750 N. San Vicente Blvd, Suite 800 West West Hollywood,  CA  90069
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-12
Decision Date2020-03-04

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