Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K101306
SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A · Fotona D.D. · decided 2011-07-01 (SESE)
FDA 510(k) database ↗Summary PDF ↗
No GUDID device is registered under this submission yet — registration typically lags clearance by months.
Devices
No matching devices.
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