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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 K242010
Device Name Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1)
Applicant
Shenzhen Sanping Image Technology Co., Ltd.
Room 203, No.634, Shajing Road,
Buchong Community, Shajing Street, Bao’an District
Shenzhen,  CN 518104
Applicant Contact Pan Vincent
Correspondent
Shenzhen Sanping Image Technology Co., Ltd.
Room 203, No.634, Shajing Road,
Buchong Community, Shajing Street, Bao’an District
Shenzhen,  CN 518104
Correspondent Contact Pan Vincent
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received07/10/2024
Decision Date 03/14/2025
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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