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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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101 to 110 of 416 results
Decision Date To: 06/09/2024
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Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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Dexcom Share Direct Secondary Displays DEXCOM, INC. DEN140038 01/23/2015
Dexcom G6 Continuous Glucose Monitoring Dexcom, Inc. DEN170088 03/27/2018
Dignitana AB DigniCap System DIGNITANA AB DEN150010 12/08/2015
Mucosal Integrity Conductivity (MI) Test Diversatek Healthcare Inc. DEN180067 12/23/2019
OMNIgene GUT Dx DNA Genotek Inc. DEN200040 11/03/2021
DreaMed Advisor Pro DreaMed Diabetes, Ltd. DEN170043 06/12/2018
GeneSTAT.MDx Coccidioides Assay DxNA, LLC DEN170041 11/29/2017
EarLens Contact Hearing Device EARLENS CORPORATION DEN150002 09/29/2015
ZAP-IT! ECOBRANDS LTD. DEN100024 11/07/2014
Acumen Assisted Fluid Management (AFM) S Edwards Lifesciences DEN190029 11/13/2020
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