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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K222910
Device Name Bronchoscope System
Applicant
Shenzhen HugeMed Medical Technical Development Co., Ltd.
416-1, 516-1, Bldg. 2, # 1, Mawu Rd., Baoan
Community, Yuanshan St., Longgang District
Shenzhen,  CN 518100
Applicant Contact Cathy S
Correspondent
Shenzhen Chonconn Medical Consulting Co., Ltd.
Rm. 504, Block C, # 1029 Nanhai Ave., Nanshan District
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received09/26/2022
Decision Date 04/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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