ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K030064
Device Name ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY
Original Applicant
SONOSITE,INC.
21919 30th drive se.
bothell, 
WA 
98021 -3904

Original Contact michael a hoffman
Regulation Number 892.1570
Classification Product Code
ITX  
Date Received 01/07/2003
Decision Date 01/22/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls