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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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Decision Date To: 06/15/2020 De Novo Products: yes
 
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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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neuropacs Automated Imaging Diagnostics, LLC DEN240071 04/03/2026
Tyto Insights for Eardrum Bulging Detect Tyto Care , Ltd. DEN250014 03/17/2026
LifeVac Lifevac, LLC DEN250012 03/04/2026
Delivery Date AI Ultrasound AI DEN250007 02/11/2026
Amferia Wound Dressing Amferia AB DEN250006 02/06/2026
Sana Device Sana Health DEN250005 01/16/2026
VitaSmart Hypothermic Oxygenated Perfusi Bridge TO Life, Ltd. DEN250009 01/15/2026
LIAISON® XL MUREX Anti-HDV (318260); LIA DiaSorin, Inc. DEN250032 12/23/2025
QIKCAP System Hai Solutions DEN250004 12/23/2025
MuReva OM™ Mureva Phototherapy, Inc. DEN240077 11/26/2025
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