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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.
ROOM 110 TOWER A FENGYU BUILDING, NO.115 FUCHENG RD
Haidian,  CN 100036
Applicant Contact Jiang Huiqi
Correspondent
MID-LINK INTERNATIONAL CO.,LTD
5/F Main Building, No.19 Gucheng Street West,
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
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