510(k) K093923

CEROX MODEL 3210 by Or-Nim Medical , Ltd. — Product Code MUD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2010
Date Received
December 22, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter, Tissue Saturation
Device Class
Class II
Regulation Number
870.2700
Review Panel
SU
Submission Type