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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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201 to 210 of 412 results
Decision Date To: 05/03/2024
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Device Name
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De Novo
Number
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510(k)
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Decision
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dermaPACE System SANUWAVE, INC. DEN160037 12/28/2017
ContaCT Viz.Al, Inc. DEN170073 02/13/2018
Banyan BTI Banyan Biomarkers, Inc. DEN170045 02/14/2018
SkinPen Precision System BELLUS MEDICAL, LLC. DEN160029 03/01/2018
23andMe PGS Genetic Health Risk Report f 23andMe, Inc. DEN170046 03/06/2018
Acumen Hypotension Prediction Index (HPI Edwards Lifesciences LLC DEN160044 03/16/2018
PrimeStore MTM Longhorn Vaccines and Diagnostics LLC DEN170029 03/19/2018
ThermoNeuroModulation Device, TNM Device Scion NeuroStim, LLC DEN170023 03/26/2018
Dexcom G6 Continuous Glucose Monitoring Dexcom, Inc. DEN170088 03/27/2018
Curetis Unyvero LRT Application Curetis GmbH DEN170047 04/03/2018
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