510(k) K842127

AMERICAN MEDICAL OPTICS IMAGING SYS by American Medical Optics — Product Code IYO

K842127 is an FDA 510(k) premarket notification submitted by American Medical Optics for the device "AMERICAN MEDICAL OPTICS IMAGING SYS". The FDA issued a decision of Substantially Equivalent on September 7, 1984. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. American Medical Optics has at least 10 other 510(k) clearances on record.