SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES)


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K021628
Device Name SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES)
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 Code
IYO  
Date Received 05/17/2002
Decision Date 05/31/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No