510(k) K111416

FALCON by Viasonix , Ltd. — Product Code JOP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2011
Date Received
May 20, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic
Device Class
Class II
Regulation Number
870.2880
Review Panel
CV
Submission Type