PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC ULTRASOUND TRANSDUCER


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K022303
Device Name PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC ULTRASOUND TRANSDUCER
Original Applicant
PHILIPS ULTRASOUND, INC.
3000 minuteman rd.
andover, 
MA 
01810

Original Contact paul smolenski
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 07/16/2002
Decision Date 07/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No