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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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Decision
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ocumap 100 autoperimeter SHORASHIM k832555 02/10/1984
lancer specimen container SHERWOOD MEDICAL CO. k812933 11/06/1981
pulse oximeter Shenzhen Yimi Life-Technology Co.,Ltd. k191430 10/18/2019
dc-90/dc-90s/dc-90q/dc-95/dc-95s/dc-88/dc-88s/dc-80a/dc-80aexp/dc-80a pro/dc-8x/dc-8q/dc-81/dc-82 diagnostic ultrasound system Shenzhen Mindray Bio-Medical Electronics Co., Ltd. k201693 08/21/2020
passport series patient monitors (including passport 8, passport 12) SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD k153448 03/03/2016
pulse oximeter Shenzhen brav electronic technologies co., Ltd k211143 07/17/2023
reusable and self-adhesive electrodes Shaoxing DongZhi Electrical Technology Co., Ltd. k180773 05/22/2018
uws-mi Shanghai United Imaging Healthcare Co.,Ltd. k172998 04/05/2018
hyper air Shanghai United Imaging Healthcare Co.,Ltd. k210001 04/30/2021
shanghai giantmax clear vinyl powder free examination gloves SHANGHAI GIANTMAX PLASTIC PRODUCT CORP. k032746 10/17/2003

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