ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc., Ultrasound Di with the FDA for Acuson S2000 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK082142
510k NumberK082142
Device Name:ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI 1230 SHOREBIRD WAY Mountain View,  CA  94043
ContactShelly Pearce
CorrespondentShelly Pearce
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI 1230 SHOREBIRD WAY Mountain View,  CA  94043
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-30
Decision Date2008-11-13
Summary:summary

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