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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 K163464
Device Name Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
Applicant
Bmc Medical., Ltd.
Rm. 110 Tower A Fengyu Bldg., #115 Fucheng Rd.
Haidian,  CN 100036
Applicant Contact Jiang Huiqi
Correspondent
Mid-Link International Co., Ltd.
5/F Main Bldg., #19 Gucheng St. W.,
Shijingshan
Beijing,  CN 100043
Correspondent Contact Jiang Huiqi
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/09/2016
Decision Date 09/05/2017
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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