BORIS PLATFORM 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 Boris Platform Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK030455
510k NumberK030455
Device Name:BORIS PLATFORM 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
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 Received2003-02-11
Decision Date2003-03-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838082953 K030455 000
00884838024304 K030455 000
00884838024649 K030455 000
00884838064553 K030455 000
00884838064652 K030455 000
00884838073524 K030455 000
00884838075146 K030455 000
00884838075177 K030455 000
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00884838080799 K030455 000
00884838081109 K030455 000
00884838082496 K030455 000
00884838082908 K030455 000
00884838082915 K030455 000
00884838082922 K030455 000
00884838082939 K030455 000
00884838023987 K030455 000

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