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

Clearance record K140318

SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER · Biosense Webster · decided 2014-03-12 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
SOUNDSTAR10439236Biosense Webster IncOBJ10846835008869
SOUNDSTAR10439011Biosense Webster IncOBJ10846835008852