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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K151663

RS80A Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · decided 2015-08-12 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
RS80A Diagnostic Ultrasound SystemUSS-RS8CF4K/USSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167755157
RS80A Diagnostic Ultrasound SystemUSS-RS8AF4K/USSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167754266