510(k) K950975

KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENS by Karl Storz Imaging, Inc. — Product Code FET

K950975 is an FDA 510(k) premarket notification submitted by Karl Storz Imaging, Inc. for the device "KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENS". The FDA issued a decision of Substantially Equivalent on May 11, 1995. The device falls under product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Karl Storz Imaging, Inc. has at least 9 other 510(k) clearances on record.