510(k) K940963

XENON LIGHT SOURCE by Incredivision, Inc. — Product Code FFS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1994
Date Received
March 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image, Illumination, Fiberoptic, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type