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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K171549
Device Name Intelligent Mesh Nebulizer
Applicant
Qingdao Future Medical Technology Co., Ltd.
Rm. 401 Bldg. F, # 169
Zhuzhou Rd., Laoshan District
Qingdao,  CN 266001
Applicant Contact Wang WeiLai
Correspondent
Beijing Believe Technology Service Co., Ltd.
5-402, Bldg. #27, Yangguangyishang, #56,
Liangxiang E. Rd., Fangshan
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/26/2017
Decision Date 08/31/2018
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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