HDI 5000 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 Hdi 5000 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK034003
510k NumberK034003
Device Name:HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant PHILIPS ULTRASOUND, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell,  WA  98041
ContactLynn Harmer
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2003-12-24
Decision Date2004-01-08
Summary:summary

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