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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 K231107
Device Name Bronchoscope System
Applicant
Hunan Endoso Life Technology Co., Ltd.
4th floor, Building 10, Innovation and Entrepreneurship
Center, 31 Dongfeng Road, Heping Street
Xiangtan,  CN 411199
Applicant Contact Fu Wang
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Room 1308, Baohua International Plaza
555 West Guangzhong Road
Shanghai,  CN 200072
Correspondent Contact Kyra Kang
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received04/19/2023
Decision Date 02/15/2024
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
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