510(k) K221329

Eyer Retinal Camera NM-STD by Phelcom Technologies — Product Code HKI

K221329 is an FDA 510(k) premarket notification submitted by Phelcom Technologies for the device "Eyer Retinal Camera NM-STD". The FDA issued a decision of Substantially Equivalent on February 22, 2023. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Phelcom Technologies has at least 1 other 510(k) clearance on record.