ACUSON Redwood Diagnostic 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 Redwood Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK210743
510k NumberK210743
Device Name:ACUSON Redwood Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Siemens Medical Solutions USA, Inc 22010 South East 51st Street Issaquah,  WA  98029
ContactSulgue Choi
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
Subsequent Product CodeOIJ
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-03-12
Decision Date2021-04-01

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