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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K243321
Device Name Endoscopic Video Image Processor (RP-IPD-V1000F)
Applicant
Guangzhou Red Pine Medical Instrument Co., Ltd.
12 F, #87 Luoxuan Ave., Guangzhou International Bioisland, H
Guangzhou,  CN 510000
Applicant Contact Weihua Wang
Correspondent
Guangzhou Red Pine Medical Instrument Co., Ltd.
12 F, #87 Luoxuan Ave., Guangzhou International Bioisland, H
Guangzhou,  CN 510000
Correspondent Contact Ping Yang
Regulation Number876.1500
Classification Product Code
FET  
Date Received10/23/2024
Decision Date 02/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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