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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K221472
Device Name Filter and HME/Filter
Applicant
Ningbo Huakun Medical Equipment Co., Ltd.
#208 Binjiang Rd.,
Cixi High-Tech Industrial Development Zone
Cixi,  CN 315301
Applicant Contact Lei Xi
Correspondent
Shanghai Puang Technology Consulting Co., Ltd.
Bldg. 5, # 525 Yuanjiang Rd., Minhang District
China,  CN 201100
Correspondent Contact Julie Chen
Regulation Number868.5260
Classification Product Code
CAH  
Date Received05/20/2022
Decision Date 02/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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