SONON Ultrasound Imaging System, Model: SONON 500L

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: Sonon 500l.

Pre-market Notification Details

Device IDK212400
510k NumberK212400
Device Name:SONON Ultrasound Imaging System, Model: SONON 500L
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Healcerion Co., Ltd 1403-ho, 12, Digital-ro 33-gil, Guro-gu Seoul,  KR 08377
ContactSooyeol Lee
CorrespondentJong Hyun Kim
GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Mapo-gu Seoul,  KR 03909
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-02
Decision Date2022-04-22

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