Class Class II

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) (K250551)

K250551 2025-10-02 Traditional
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Description

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) by Shenzhen Sophway Technology Co., Ltd., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250551
Clearance Date2025-10-02
Clearance TypeTraditional
Product CodeGCJ
Regulation Number876.1500

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