FDA 510(k) Applications Submitted by Yang Yang

FDA 510(k) Number Submission Date Device Name Applicant
K211361 05/03/2021 3N Contact Lenses Adjunct Cleaner Suzhou 3N Biological Technology Co., Ltd
K213947 12/17/2021 Ultrasonic Endo Activation Device (Model:Actor I pro) ChangZhou BoMedent Medical Technology Co.,Ltd
K222907 09/26/2022 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate RMKH Glove (Cambodia) Co., Ltd.
K212092 07/06/2021 Portable Folding Electric Wheelchair (Model: DC01) Anhui JBH Medical Apparatus Co., Ltd
K170965 03/31/2017 Fingertip Pulse Oximeter Shenzhen Jumper Medical Equipment Co., Ltd.
K211750 06/07/2021 Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) National Bridge Industrial (S.Z.) Co., Ltd.
K210475 02/17/2021 EQ-M Meta Systems Co., Ltd
K141874 07/11/2014 URISCAN OPTIMA YD DIAGNOSTICS CORP.
K132313 07/25/2013 PESSARY EIS CORPORATION
K102188 08/03/2010 CYBOW READER, MODELS 300 & 720 DFI CO., LTD.
K192048 07/31/2019 Single Use Endoscope Valves Set Anrei Medical (Hangzhou) Co., Ltd.
K170545 02/24/2017 Automatic Wrist Bluetooth Blood Pressure Monitor Truly Instrument Ltd.
K090564 03/02/2009 TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 TRULY INSTRUMENT LIMITED
K091415 05/13/2009 TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M TRULY INSTRUMENT CO., LTD.
K161846 07/05/2016 Automatic Arm Bluetooth Blood Pressure Monitor TRULY INSTRUMENT LIMITED
K081852 06/30/2008 TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 TRULY INSTRUMENT LIMITED
K223709 12/12/2022 Kyphoplasty Balloon Catheter Jiangsu Changmei Medtech Co., Ltd.
K171889 06/26/2017 Reusable Blood Pressure Cuff Suzhou Minhua Medical Apparatus Supplies Co., LTD
K210578 02/26/2021 Medical Nitrile Examination Gloves (Power free, Blue) Jiangxi Hongda Medical Equipment Group Ltd.
K210821 03/19/2021 Medical PVC Examination Gloves Jiangxi Hongda Medical Equipment Group Ltd.
K002727 08/31/2000 YOUNG-HEALTH SUPER EAR THERMOMETER YOUNG HEALTH IND. CO., LTD.
K170281 01/30/2017 MSA100BT Peak Flow Meter Beijing M&B Electronic Instruments Co., Ltd.
K180984 04/13/2018 Maxcon Sharps Container Ningbo Maxcon Medical Technology Co., Ltd.
K180983 04/13/2018 Maxcon Two Gallon Chemotherapy Container Ningbo Maxcon Medical Technology Co., Ltd.
K203410 11/19/2020 ENFit Disposable Enteral Syringe Shantou Wealy Medical Instrument Co., Ltd.
K203613 12/10/2020 ENFit Reusable Enteral Syringe Shantou Wealy Medical Instrument Co., Ltd.
K151936 07/14/2015 Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle SYNAPTIC MEDICAL LIMITED
K011913 06/19/2001 SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES SUN-RAIN SYSTEM CORP.
K012796 08/21/2001 AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000 AMLUCK, INC.
K121527 05/23/2012 WI-FI BODY SCALE SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD
K203685 12/17/2020 Disposable Surgical Face Mask Xiantao Zhongyi Safety & Protection Products Co., Ltd
K163162 11/10/2016 Sterile Hypodermic Safety Syringes for Single Use JiangXi HongDa Medical Equipment Group Ltd.
K163161 11/10/2016 Sterile Single-use Syringe with Needle JiangXi HongDa Medical Equipment Group Ltd.
K190397 02/19/2019 Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA Immunalysis Corporation
K210367 02/08/2021 D-Laser Blue, D-Laser 16 Guilin Woodpecker Medical Instrument Co., Ltd.
K211358 05/03/2021 Implanter incl. Accessories Guilin Woodpecker Medical Instrument Co., Ltd.
K150204 01/29/2015 DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K170277 01/30/2017 DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K121010 04/03/2012 M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K180912 04/06/2018 TE7/TE5 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd
K171579 05/31/2017 M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd
K131690 06/10/2013 M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K122010 07/09/2012 Z6 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K152545 09/08/2015 DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K172970 09/26/2017 M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound ShenZhen Mindray Bio-Medical Electronics Co., Ltd
K173471 11/08/2017 DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Shenzhen Mindray Bio-medical Electronics Co., LTD
K143472 12/05/2014 TE7 Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K163690 12/28/2016 DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K122393 08/07/2012 TG-BODY MI&BODY S-TRAINER MIGA MEDICAL CO., LTD.
K122410 08/08/2012 I RUNE (I-200L) MEDIRUNE CO, LTD
K230759 03/20/2023 SafeLan« (2 models/SafeLan 26G, SafeLan 30G), SafeLan«-Pro (1 model/SafeLan«-Pro) Bosungmeditech Co., Ltd.
K162259 08/11/2016 DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) ZIBO DAIYANG PLASTIC COMPANY
K211335 05/03/2021 Diode Laser Machine, Model Number: BM-100 Zhengzhou Bestview St Co., Ltd.
K211735 06/07/2021 CO2 Laser Machine, Model: BW-203B Zhengzhou Bestview St Co., Ltd.
K091434 05/13/2009 TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M TRULY INSTRUMENT CO., LTD.
K083602 12/05/2008 KAPPA LIGHT CHAINS SENTINEL CH. SpA
K083601 12/05/2008 LAMBDA LIGHT CHAINS SENTINEL CH. SpA


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