ACUSON P50 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 P50 Ultrasound System.

Pre-market Notification Details

Device IDK083114
510k NumberK083114
Device Name:ACUSON P50 ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY P O BOX 7393 Mountain View,  CA  94039 -7393
ContactSheila W Pickering
CorrespondentSheila W Pickering
SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY P O BOX 7393 Mountain View,  CA  94039 -7393
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-21
Decision Date2009-03-31
Summary:summary

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