510(k) K061622

PS SERIES by Photonic Optische Gerate Gesmbh & Cokg — Product Code FFS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2007
Date Received
June 12, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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