Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K103604
ISA CO2, ISA AX+, ISA OR+ · Phasein AB · decided 2011-04-06 (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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