ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

SIEMENS MEDICAL SOLUTIONS USA, INC.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Acuson Sequoia Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK051139
510k NumberK051139
Device Name:ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY P O BOX 7393 Mountain View,  CA  94039 -7393
ContactIskra Mrakovic
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 Received2005-05-04
Decision Date2005-05-13
Summary:summary

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