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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.
No.208 Binjiang Road, Cixi High-tech Industrial Development
Zone
Cixi,  CN 315301
Applicant Contact Lei Xi
Correspondent
Shanghai Puang Technology Consulting Co., Ltd.
Building 5, No.525 Yuanjiang Road, Minhang District
Shanghai,  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
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