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510(k) Data Aggregation

K Number

Device Name

Endoscopic Camera System

Manufacturer

Shenzhen Sophway Technology Co., Ltd.

Date Cleared

2025-07-01

(158 days)

Product Code

FET

Regulation Number

876.1500

Why did this record match?

Applicant Name (Manufacturer) :

Shenzhen Sophway Technology Co., Ltd.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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