BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K030455
Device Name BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
PHILIPS ULTRASOUND, INC.
22100 bothell everett hwy.
p.o. box 3003
bothell, 
WA 
98041

Applicant Contact lynn harmer
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 02/11/2003
Decision Date 03/13/2003
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