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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K190274
Device Name Endotracheal Tube
Applicant
Tianjin Medis Medical Device Co., Ltd.
# 15-A, Saida One Ave., Xiqing Economic Development Area
Tainjin,  CN 300385
Applicant Contact Yongzhi Wu
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number868.5730
Classification Product Code
BTR  
Date Received02/08/2019
Decision Date 07/30/2019
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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