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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K191550
Device Name Broncholab
Applicant
Fluidda Inc.
750 N. San Vicente Blvd, Suite 800 West
West Hollywood,  CA  90069
Applicant Contact Anjali Nair
Correspondent
Fluidda Inc.
750 N. San Vicente Blvd, Suite 800 West
West Hollywood,  CA  90069
Correspondent Contact Anjali Nair
Regulation Number892.1750
Classification Product Code
JAK  
Date Received06/12/2019
Decision Date 03/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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