SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K023957
Device Name SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)
Original Applicant
SONOSITE,INC.
21919 30th drive se.
bothell, 
WA 
98021 -3904

Original Contact michael a hoffman
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 11/27/2002
Decision Date 12/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No