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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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141 to 150 of 416 results
Decision Date To: 06/03/2024
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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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PEDIATRIC VISION SCANNER REBISCAN, INC. DEN130051 06/08/2016
PAXGENE BLOOD RNA SYSTEM PREANALYTIX GMBH DEN050003 K042613 04/18/2005
Parsortix PC1 Device ANGLE Europe Ltd. DEN200062 05/24/2022
Parathyroid Detection (Model PTeye) Syst AiBiomed, Corp. DEN170056 11/02/2018
Parallel Mahana Therapeutics, Inc. DEN200029 11/25/2020
Paige Prostate Paige.AI DEN200080 09/21/2021
Oxehealth Vital Signs Oxehealth Limited DEN200019 03/26/2021
OVA1 TEST VERMILLION DEN090004 K081754 09/11/2009
OsteoProbe Active Life Scientific, Inc. DEN210013 08/19/2021
OsteoDetect Imagen Technologies, Inc. DEN180005 05/24/2018
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