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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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81 to 90 of 416 results
Decision Date To: 06/13/2024
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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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PMD-200 Medasense Biometrics Ltd. DEN210022 02/17/2023
Sunrise Sleep Disorder Diagnostic Aid Sunrise DEN210015 01/07/2022
EaseVRx AppliedVR, Inc. DEN210014 11/16/2021
OsteoProbe Active Life Scientific, Inc. DEN210013 08/19/2021
vPatch Virility Medical DEN210012 11/23/2021
Invitae Common Hereditary Cancers Panel Invitae Corporation DEN210011 09/29/2023
Hemolung Respiratory Assist System ALung Technologies, Inc. DEN210006 11/13/2021
Luminopia One Luminopia, Inc. DEN210005 10/20/2021
Zuno Smart Sterilization Container Zuno Medical, Inc. DEN210004 06/17/2022
SureTune4 Software Medtronic Neuromodulation DEN210003 08/23/2021
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