510(k) K893035

OPHTHASCAN 'S' MINI-A by Biophysic Medical, Inc. — Product Code IYO

K893035 is an FDA 510(k) premarket notification submitted by Biophysic Medical, Inc. for the device "OPHTHASCAN 'S' MINI-A". The FDA issued a decision of Substantially Equivalent on June 12, 1989. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Biophysic Medical, Inc. has at least 10 other 510(k) clearances on record.