CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS

Transducer, Ultrasonic, Diagnostic

PHILIPS ULTRASOUND, INC.

The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Cx50 Version 2.0 Diagnostic Ultrasound System And Transducers.

Pre-market Notification Details

Device IDK091804
510k NumberK091804
Device Name:CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant PHILIPS ULTRASOUND, INC. 3000 MINUTEMAN RD. Andover,  MA  01810
ContactRob Butler
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeITX  
Subsequent Product CodeIYN
Subsequent Product CodeIYO
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-06-18
Decision Date2009-07-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838087163 K091804 000
00884838067882 K091804 000
00884838067875 K091804 000
00884838067868 K091804 000
00884838067844 K091804 000
00884838061668 K091804 000
00884838061613 K091804 000
00884838061491 K091804 000
00884838028098 K091804 000

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