510(k) K920026

NOBLES-LAI IMAGING SYSTEM by Nobles-Lai Engineering, Inc. — Product Code FET

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
July 28, 1992
Date Received
January 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.