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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 K211155
Device Name Auto CPAP System
Applicant
BMC Medical Co., Ltd.
Room 901, Building 1, No. 28 Pingguoyuan Road
Beijing,  CN 100041
Applicant Contact Amy Wang
Correspondent
BMC Medical Co., Ltd.
Room 901, Building 1, No. 28 Pingguoyuan Road
Beijing,  CN 100041
Correspondent Contact Amy Wang
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/19/2021
Decision Date 03/09/2022
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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