ACUSON S2000 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 S2000 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK093812
510k NumberK093812
Device Name:ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY Mountain View,  CA  94043
ContactShelly Pearce
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 Received2009-12-11
Decision Date2010-03-03
Summary:summary

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