510(k) K923348

OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED by Zeiss Humphrey System — Product Code ITX

K923348 is an FDA 510(k) premarket notification submitted by Zeiss Humphrey System for the device "OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED". The FDA issued a decision of Substantially Equivalent on December 10, 1992. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Zeiss Humphrey System has at least 8 other 510(k) clearances on record.