HD7 DIAGNOSTIC ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K080548
Device Name HD7 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
PHILLIPS MEDICAL SYSTEMS
22100 bothell everett highway
bothell, 
WA 
98021

Applicant Contact nancy burke
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 02/28/2008
Decision Date 03/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No