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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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91 to 100 of 413 results
Decision Date To: 05/15/2024
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Download Files | More About De Novo
Device Name
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Requester
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De Novo
Number
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510(k)
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Decision
Date
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GI Genius Cosmo Artificial Intelligence - AI, LTD DEN200055 04/09/2021
ProdiGI Covidien LLC DEN220006 06/13/2022
Cue COVID-19 Molecular Test Cue Health Inc. DEN220028 06/06/2023
Curetis Unyvero LRT Application Curetis GmbH DEN170047 04/03/2018
MLL (KMT2A) Breakapart FISH Probe Kit; A Cytocell Ltd DEN170070 12/21/2018
BrainSee Darmiyan, Inc. DEN220066 01/11/2024
DermaSensor DermaSensor Inc. DEN230008 01/12/2024
STUDIO ON THE CLOUD DATA MANAGEMENT SOFT DEXCOM, INC. DEN140016 08/19/2014
Dexcom Share Direct Secondary Displays DEXCOM, INC. DEN140038 01/23/2015
Dexcom G6 Continuous Glucose Monitoring Dexcom, Inc. DEN170088 03/27/2018
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