HS40 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 Hs40 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK172129
510k NumberK172129
Device Name:HS40 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Samsung Medison Co., Ltd. 42, Techeran-ro 108-gil, Gangnam-gu, Seoul,  KR
ContactJiyeon Cho
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 Received2017-07-14
Decision Date2017-08-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806167783327 K172129 000
08806167782948 K172129 000
08806167759834 K172129 000
08806167749880 K172129 000
08809702985729 K172129 000
08809702980663 K172129 000
08809702985668 K172129 000
08809702980601 K172129 000

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