510(k) K963333

OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) by Karl Storz Imaging, Inc. — Product Code HKI

K963333 is an FDA 510(k) premarket notification submitted by Karl Storz Imaging, Inc. for the device "OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)". The FDA issued a decision of Substantially Equivalent on October 22, 1996. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Karl Storz Imaging, Inc. has at least 9 other 510(k) clearances on record.