SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

System, Imaging, Pulsed Echo, Ultrasonic

MEDISON CO., LTD.

The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Sonoace 4500 Diagnostic Ultrasound Imaging System.

Pre-market Notification Details

Device IDK910342
510k NumberK910342
Device Name:SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant MEDISON CO., LTD. 148 YANG DUK WON-RI, NAM-MYUN, HONG CHUN-KUN Kang Won-do,  KR
ContactRobert D Waxham
CorrespondentRobert D Waxham
MEDISON CO., LTD. 148 YANG DUK WON-RI, NAM-MYUN, HONG CHUN-KUN Kang Won-do,  KR
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-28
Decision Date1991-08-19

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