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

Clearance record K213263

OnyxCeph · Image Instruments GmbH · decided 2023-01-04 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
OnyxCeph³3.2Image Instruments GmbHLLZ PNND981ONYXCEPH320