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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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vsm(r) r2 paper chart recorder Physio-Control Corp. k880554 05/06/1988
wallflex colonic soft stent system with anchor lock delivery system, wallflex duodenal soft stent system with anchor lock delivery system Boston Scientific Corporation k200257 04/17/2020
webster cs catheter with ez steer technology, webster cs catheter with ez steer technology and auto id model: d-1263-04, Biosense Webster, Inc. k101345 06/22/2010
wireless intelligent thermometer Shenzhen Jumper Medical Equipment Co., Ltd. k182437 05/05/2019
wondfo amphetamine urine test amp 500 (cup, dipcard), wondfo cocaine urine test coc 150(cup, dipcard), wondfo methamphetamine urine test met 500 (cup, dipcard) Guangzhou Wondfo Biotech Co., Ltd. k161214 06/27/2016
xtag gastrointestinal pathogen panel(gpp)/xtag data analysis software for gpp(tdas gpp) Luminex Molecular Diagnostics, Inc. k140647 10/24/2014
ziehm vision fd digital mobile imaging system Ziehm Imaging, Inc. k061534 07/07/2006
zonograph 6 Siemens Corp. k810307 03/11/1981
zs3 and z.one pro ultrasound systems Shenzhen Mindray Bio-Medical Electronics Co., Ltd. k192410 12/19/2019

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