Table, Instrument, Manual, Ophthalmic

FDA product code HRK · Class I (low risk) · 21 CFR 886.4855 · Ophthalmic

2510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K842410Amer. Edwards Lab FlexiscopeHRK · Traditional American Edwards Laboratories11/05/1984SE
K760697Evans Arm and Hand RestHRK · Traditional Alcon Laboratories11/02/1976SE