FDA 510(k) Applications Submitted by Li Chen
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K240841 |
03/27/2024 |
Digital Radiography System (ManntiX B, ManntiX K) |
Shenzhen Browiner Tech Co., Ltd |
| K221567 |
05/31/2022 |
LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) |
Qingdao Hisense Medical Equipment Co., Ltd. |
| K242740 |
09/11/2024 |
Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) |
Liaoning Rachcera Material Technology Co.,Ltd. |
| K210288 |
02/02/2021 |
Disposable Manual Resuscitator |
Xiamen Compower Medical Tech. Co., Ltd. |
| K171961 |
06/30/2017 |
Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) |
Xiamen Compower Medical Tech. Co. Ltd. |
| K222442 |
08/12/2022 |
DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) |
Anhui Bytech Medical Supplies Co., Ltd. |
| K111387 |
05/17/2011 |
LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER |
IQUUM INC |
| K141338 |
05/21/2014 |
LIAT STREP A ASSAY |
IQUUM INC |
| K153544 |
12/11/2015 |
cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System |
IQuum, Inc. |
| K964358 |
11/01/1996 |
AMSEAL SURGICAL FACE MASK |
AMERICAN SEAL CO. |
| K202714 |
09/16/2020 |
Medical Face Mask |
Chongqing Chaoke Industry Development Co., Ltd. |
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