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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 K133009
Device Name NASAL MASK, NASAL MASK, FULL FACE MASK
Applicant
BMC MEDICAL CO., LTD
5/F Main Building
No.19 Gucheng Street West,Shijingshan
Beijing,  CN 100043
Applicant Contact MS. JINJING
Correspondent
BMC MEDICAL CO., LTD
5/F Main Building
No.19 Gucheng Street West,Shijingshan
Beijing,  CN 100043
Correspondent Contact MS. JINJING
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/25/2013
Decision Date 04/23/2014
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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