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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
Date
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o2 connector DIEMOLDING CORP. k780750 07/27/1978
digiflo concentrator analyzer DIGIFLO, INC. k072469 01/03/2008
sellas DINONA CO., LTD. k080382 09/24/2008
permacem / permacem dual DMG USA, INC. k012316 08/23/2001
tens&ems stimulator (model: kres100d, kres1010, kres1020, kres1080) Dongguan Bohuikang Technology Co.,Ltd k213788 05/06/2022
solax powered wheelchair Dongguan Prestige Sporting Goods Co., Ltd k182576 05/21/2019
planet onco dose DOSIsoft k182966 03/06/2019
modified rongeurs for spinal & orth. s. DOWNS SURGICAL LTD. k821358 05/28/1982
screeners cocaine test; drugscreen dip cocaine test DRUG DETECTION DEVICES, LTD. k000350 04/11/2000
napa lp-15 airway pressure monitor DRW Medical, LLC k172284 02/09/2018

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