CX50 Diagnostic Ultrasound System, Sparq 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 Cx50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK162329
510k NumberK162329
Device Name:CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Philips Healthcare 22100 Bothell Everett Highway Bothell,  WA  98021 -8431
ContactMaxs Newberry
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 Received2016-08-19
Decision Date2016-09-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838040120 K162329 000
00884838103214 K162329 000
00884838098008 K162329 000
00884838097964 K162329 000

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