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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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510(K)
Number
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Decision
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merit syringe Merit Medical Systems, Inc. k182216 11/06/2018
handheld vitalsigns monitoring system Visiomed Technology Co.,Ltd k172965 12/17/2018
revive reusable bladder support Rinovum Subsidiary 2, LLC k183468 01/25/2019
safety insulin needle for single use Berpu Medical Technology Co., Ltd. k181447 03/12/2019
aristotle 18 guidewire, 200cm, soft profile ; aristotle 18 guidewire, 200cm, standard profile ; aristotle 18 guidewire, 200cm, support profile Scientia Vascular, LLC k183608 03/22/2019
connect app for ihealth next, ihealth react native sdk, ihealth react native library sdk, ihealth library sdk, ihealth native sdk Andon Health Co, Ltd. k181541 04/16/2019
huvitz imaging system Huvitz Co., Ltd. k191615 07/18/2019
yushan x-ray flat panel detector Innocare Optoelectronics Corp. k191939 08/29/2019
supascoota motorized vehicle - spartan (sumo)/ spartan sp (sumo sp) Eurogreen International, Inc. k182631 09/19/2019
atlas multi-drugs screening test cup, atlas multi-drugs screening test panel Atlas Medical k191099 10/03/2019

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