510(k) K093192

FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE by Advanced Vascular Dynamics — Product Code JOM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2010
Date Received
October 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class
Class II
Regulation Number
870.2780
Review Panel
CV
Submission Type