ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

Siemens Medical Solutions, Inc.

The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Acuson S1000 / S2000 / S3000 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK162243
510k NumberK162243
Device Name:ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Siemens Medical Solutions, Inc. 685 E MIDDLEFIELD RD 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
Subsequent Product CodeOBJ
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2016-08-10
Decision Date2016-09-06
Summary:summary

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