CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

PHILIPS HEALTHCARE

The following data is part of a premarket notification filed by Philips Healthcare with the FDA for Clearvue 350/550 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK120321
510k NumberK120321
Device Name:CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant PHILIPS HEALTHCARE 3000 MINUTEMAN RD Andover,  MA  01810
ContactRob Butler
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 Received2012-02-02
Decision Date2012-02-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00884838097667 K120321 000

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