RS80A DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

SAMSUNG MEDISON CO., LTD

The following data is part of a premarket notification filed by Samsung Medison Co., Ltd with the FDA for Rs80a Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK141620
510k NumberK141620
Device Name:RS80A DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SAMSUNG MEDISON CO., LTD 42, TEHERAN-RO 108-GIL Gangnam-gu, Seoul,  KR 135-280
ContactPark Kyeong-mi
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 Received2014-06-17
Decision Date2014-07-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806167748920 K141620 000

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