510(k) K023957

SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES) by Sonosite,Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2002
Date Received
November 27, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type