Healcerion Co., Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Healcerion Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: SONON Ultrasound Imaging System, Model: SONON300C, SONON Ultrasound Imaging System, Model: SONON 500L
4
Total
4
Cleared
0
Denied
Healcerion Co., Ltd. has 4 FDA 510(k) cleared medical devices. Based in Seoul, KR.
Last cleared in 2022. Active since 2015. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Healcerion Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Gms Consulting and Gms Consulting Co., Ltd..
FDA 510(k) Regulatory Record - Healcerion Co., Ltd.
4 devices
Cleared
May 16, 2022
SONON Ultrasound Imaging System, Model: SONON300C
Radiology
349d
Cleared
Apr 22, 2022
SONON Ultrasound Imaging System, Model: SONON 500L
Radiology
263d
Cleared
Oct 12, 2017
SONON Ultrasound Imaging System, Model: 300L
Radiology
275d
Cleared
Sep 10, 2015
SONON Ultrasound Imaging System (Model: SONON 300C)
Radiology
114d