ClearVue850 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 Clearvue850 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK153480
510k NumberK153480
Device Name:ClearVue850 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant PHILIPS HEALTHCARE 22100 BOTHELL EVERETT HIGHWAY Bothell,  WA  98021 -8431
ContactSaraswathi Deora
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 Received2015-12-02
Decision Date2015-12-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838057623 K153480 000

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