FDA 510(k) Applications Submitted by Hong Hyeon An
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K212904 |
09/13/2021 |
SeaSpine WaveForm C Interbody System |
SeaSpine Orthopedics Corporation |
| K213359 |
10/12/2021 |
SeaSpine WaveForm, C Interbody System |
SeaSpine Orthopedics Corporation |
| K180075 |
01/10/2018 |
MINUET LCD, MINUET LCD eco |
Unimom Co. |
| K241694 |
06/12/2024 |
ZeTTA PACS |
Tae Young Soft Co., Ltd. |
| K223037 |
09/29/2022 |
Infrared Thermometer, Model: IR8807 |
Shen Zhen Rong Feng Technology Co., Ltd |
| K223044 |
09/29/2022 |
Digital Thermometer (Model QT001) |
Shen Zhen Rong Feng Technology Co., Ltd |
| K191106 |
04/25/2019 |
C50 and C80 Multi-parameter Patient Monitor |
Shenzhen Comen Medical Instruments Co.,Ltd. |
| K211619 |
05/26/2021 |
Multi-Parameter Patient Monitor |
Shenzhen Comen Medical Instruments CO., LTD. |
| K173454 |
11/06/2017 |
Multi-parameter Patient Monitor, models C30 |
Shenzhen Comen Medical Instruments Co.,Ltd. |
| K230024 |
01/04/2023 |
HI-EMT MAGSHAPE |
Beijing Sano Laser S&T Development Co., Ltd |
| K191970 |
07/24/2019 |
Diode Laser Hair Removal System |
Beijing Sano Laser S&T Development Co., Ltd |
| K202061 |
07/27/2020 |
Medical Face mask |
Jiangsu Province Jianerkang Medical Dressing Co., Ltd |
| K221321 |
05/06/2022 |
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System |
GE Medical Systems Information Technologies, Inc. |
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