ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

SIEMENS MEDICAL SOLUTION

The following data is part of a premarket notification filed by Siemens Medical Solution with the FDA for Acuson S3000 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK121138
510k NumberK121138
Device Name:ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SIEMENS MEDICAL SOLUTION 1230 SHOREBIRD WAY Mountainview,  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 Received2012-04-13
Decision Date2012-05-17
Summary:summary

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