ACUSON S2000 ULTRASOUND SYSTEM

Transducer, Ultrasonic, Diagnostic

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 Ultrasound System.

Pre-market Notification Details

Device IDK072786
510k NumberK072786
Device Name:ACUSON S2000 ULTRASOUND SYSTEM
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY Mountain View,  CA  94039
ContactShelly Pearce
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeITX  
Subsequent Product CodeIYN
Subsequent Product CodeIYO
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-10-01
Decision Date2007-11-13
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.