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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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21 to 30 of 416 results
Decision Date To: 06/01/2024
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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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BrainSee Darmiyan, Inc. DEN220066 01/11/2024
BioTraceIO Lite TechsoMed Medical Technologies Ltd. DEN230020 12/22/2023
Body Temperature Software (BTS) Fitbit LLC DEN230050 12/15/2023
NaviCam ProScan Ankon Technologies Co., Ltd DEN230027 12/12/2023
Sonu Sound Health Systems, Inc. DEN230045 12/04/2023
Simple 2 Test LetsGetChecked Inc. (formerly PrivaPath DEN200070 11/15/2023
Dream Sock Owlet Baby Care, Inc. DEN220091 11/08/2023
EasySep™ Human Bone Marrow CD138 Positiv STEMCELL Technologies Canada Inc. DEN220090 11/06/2023
ORi Masimo Corporation DEN200076 10/12/2023
Edison System HistoSonics, Inc. DEN220087 10/06/2023
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