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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: 06/01/2024
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Device Name
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De Novo
Number
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510(k)
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Decision
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ZANZA-CLICK TECNIMED S.R.L. DEN130019 11/07/2014
BrainScope Ahead 100 BRAINSCOPE COMPANY, INC DEN140025 11/17/2014
HEARTFLOW FFRCT HEARTFLOW DEN130045 11/26/2014
PERKINELMER ENLITE NEONATAL TREC TEST SY WALLAC OY DEN140010 12/15/2014
AMIGO REMOTE CATHETER SYSTEM CATHETER ROBOTICS INC DEN140009 12/18/2014
MOERAE SURGICAL MARKING PEN MOERAE MATRIX, INC. DEN130004 12/18/2014
Dexcom Share Direct Secondary Displays DEXCOM, INC. DEN140038 01/23/2015
ECLIPSE SYSTEM PELVALON DEN140020 02/12/2015
23ANDME PERSONAL GENOME SERVICE (HEREINA 23andMe DEN140044 02/19/2015
REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPH SOMNA THERAPEUTICS, LLC DEN130046 03/06/2015
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