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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 K251894
Device Name Himaging Bronchscope System
Applicant
Himaging Technology (Shanghai) Co., Ltd.
Rm. 2601 And 2605 (Nominal Rm. 2801 And 2805),
# 418 Guiping Rd., Xuhui District
Shanghai,  CN 200233
Applicant Contact Shumei Xu
Correspondent
Himaging Technology (Shanghai) Co., Ltd.
Rm. 2601 And 2605 (Nominal Rm. 2801 And 2805),
# 418 Guiping Rd., Xuhui District
Shanghai,  CN 200233
Correspondent Contact Shumei Xu
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received06/20/2025
Decision Date 09/23/2025
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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