HD11 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 Hd11 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK043535
510k NumberK043535
Device Name:HD11 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant PHILIPS ULTRASOUND, INC. 3000 MINUTEMAN RD. Andover,  MA  01810
ContactSteve Singlar
CorrespondentLaura Danielson
TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-12-22
Decision Date2005-01-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838076754 K043535 000
00884838068070 K043535 000

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