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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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41 to 50 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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NaviCam Capsule Endoscope System with Na AnX Robotica, Inc. DEN190037 05/22/2020
APOLLO ESG System, APOLLO ESG SX System, Apollo Endosurgery, Inc. DEN210045 07/12/2022
Irregular Rhythm Notification Feature Apple Inc DEN180042 09/11/2018
ECG App Apple Inc DEN180044 09/11/2018
EaseVRx AppliedVR, Inc. DEN210014 11/16/2021
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR APTUS ENDOSYSTEMS, INC. DEN100026 K102333 11/21/2011
REWALK ARGO MEDICAL TECHNOLOGIES, INC. DEN130034 K131798 06/26/2014
ARK Voriconazole II Assay Test System ARK DIAGNOSTICS, INC DEN160033 05/05/2017
PROSTATE MECHANICAL IMAGER ARTANN LABORATORIES, INC DEN100016 K093579 04/27/2012
GLUCATELL ASSOCIATES OF CAPE COD, INC. DEN040003 K032373 05/21/2004
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