SONON Ultrasound Imaging System, Model: 300L

System, Imaging, Pulsed Doppler, Ultrasonic

HEALCERION CO., LTD

The following data is part of a premarket notification filed by Healcerion Co., Ltd with the FDA for Sonon Ultrasound Imaging System, Model: 300l.

Pre-market Notification Details

Device IDK170085
510k NumberK170085
Device Name:SONON Ultrasound Imaging System, Model: 300L
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant HEALCERION CO., LTD 804HO, 38-21, DIGITAL-RO 31-GIL, GURO-GO Seoul,  KR 08376
ContactJaeyeob Jung
CorrespondentCarmelina G. Allis
THE ALLIS LAW FIRM, PLLC 2437 BAY AREA BLVD., #30 Houston,  TX  77058
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-10
Decision Date2017-10-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860000879842 K170085 000
00860000879835 K170085 000
08809489920012 K170085 000

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