510(k) K102179

ENVIEW (TM) by Carefusion 2200 — Product Code OCV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2010
Date Received
August 3, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Holder
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To hold endoscope in a desired position during procedures.