HM70A 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 Hm70a Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK153408
510k NumberK153408
Device Name:HM70A Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SAMSUNG MEDISON CO., LTD 42, TEHERAN-RO 108-GIL GANGNAM-GU Seoul,  KR 135-851
ContactJiyoung Kim
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 Received2015-11-25
Decision Date2015-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806167790080 K153408 000
08809702985538 K153408 000

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