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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K192177
Device Name SysMed S/T
Applicant
Sysmed (China) Co., Ltd.
11-2-3 # 17 Wensu St. , Hunnan New Dis.
Shenyang,  CN 110171
Applicant Contact Yue Jian
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/12/2019
Decision Date 11/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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