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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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71 to 80 of 416 results
Decision Date To: 06/07/2024
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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)
Number
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Decision
Date
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SENSIMED TRIGGERFISH SENSIMED AG DEN140017 03/04/2016
Eversense AP CGM System Senseonics, Incorporated DEN230052 04/29/2024
X100 with Full Field Bone Marrow Aspirat Scopio Labs Ltd. DEN230034 03/22/2024
ThermoNeuroModulation Device, TNM Device Scion NeuroStim, LLC DEN170023 03/26/2018
Sensor Monitored Alimentary Restriction SCIENTIFIC INTAKE DEN150033 09/26/2016
Early Bird Bleed Monitoring System Saranas, Inc. DEN180021 03/01/2019
dermaPACE System SANUWAVE, INC. DEN160037 12/28/2017
Sleep Apnea Feature Samsung Electronics Co., Ltd DEN230041 02/06/2024
MyCare Psychiatry Clozapine Assay Kit Saladax Biomedical Inc DEN190028 04/16/2020
FETAL PILLOW SAFE OBSTETRIC SYSTEMS LTD DEN150053 07/27/2017
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