FDA 510(k) Applications Submitted by Chao Hao
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K212221 |
07/16/2021 |
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer |
Diazyme Laboratories Inc. |
| K203136 |
10/20/2020 |
Diazyme PLAC« Test for Lp-PLA2 Activity |
Diazyme Laboratories Inc. |
| K223724 |
12/13/2022 |
MOZI TPS |
Manteia Technologies Co., Ltd. |
| K202371 |
08/19/2020 |
Highspeed Airturbine Handpiece |
Beijing Dongbo Dental Handpiece Co., Ltd. |
| K173561 |
11/17/2017 |
Vinyl Patient Examination Glove (Yellow) |
Yurun Glove Co., Ltd. |
| K173580 |
11/20/2017 |
Vinyl Patient Examination Glove (Yellow) |
Nature Medical Products Co.,Ltd. |
| K220113 |
01/14/2022 |
Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) |
Shenzhen Finicare Co., Ltd. |
| K181215 |
05/07/2018 |
Infrared Thermometer |
Shenzhen Finicare Co., Ltd. |
| K231367 |
05/11/2023 |
Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) |
Shenzhen Finicare Co., Ltd. |
| K171148 |
04/19/2017 |
Aleo BME Liquid Bandage |
Aleo BME Inc. |
| K142470 |
09/03/2014 |
E-Shield Multi-paried Subdermal Needle Electrodes |
NEUROINVENT INC. |
| K142751 |
09/24/2014 |
Chang Gung ComMed Series Dental Implant System |
Chang Gung Medical Technology Co., Ltd. |
| K060208 |
01/27/2006 |
CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C, |
LIFE-SHIELD PRODUCTS, INC |
| K140200 |
01/27/2014 |
E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES |
NEUROINVENT INC. |
| K093043 |
09/30/2009 |
ZIRCONIA SYRINGE NEEDLE |
KUO TAI HOSPITAL MANAGEMENTS & CONSULTANT CO., LTD |
| K222537 |
08/22/2022 |
IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi |
Shenzhen Ishine Technology Company Limited |
| K120685 |
03/06/2012 |
ZYNO MEDICAL ADMINISTRATION SET |
ZYNO MEDICAL LLC |
| K100705 |
03/12/2010 |
ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 |
ZYNO MEDICAL LLC |
| K071545 |
06/06/2007 |
Z-800 VOLUMETRIC INFUSION PUMP |
ZYNO MEDICAL LLC |
| K203662 |
12/15/2020 |
Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 |
Yibin Junxin Electronics Technology Co., Ltd. |
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