CX50 DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

PHILIPS ULTRASOUND, INC.

The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Cx50 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK111513
510k NumberK111513
Device Name:CX50 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant PHILIPS ULTRASOUND, INC. 3000 MINUTEMAN ROAD Andover,  MA  01810 -6302
ContactPenny Greco
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-06-01
Decision Date2011-06-24
Summary:summary

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