FDA 510(k) Applications Submitted by Jin Ho An

FDA 510(k) Number Submission Date Device Name Applicant
K170514 02/21/2017 Central Monitoring System Guangdong Biolight Meditech Co., Ltd.
K151287 05/14/2015 Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D GUANGDONG BIOLIGHT MEDITECH CO., LTD.
K153135 10/30/2015 VITAL SIGNS MONITOR GUANGDONG BIOLIGHT MEDITECH CO., LTD.
K153580 12/15/2015 Central Monitoring System GUANGDONG BIOLIGHT MEDITECH CO., LTD.
K210381 02/09/2021 I.V. Administration Set BQ PLUS Medical Co., Ltd.
K223645 12/06/2022 I.V. Administration Set, I.V. Extension Set BQ PLUS Medical Co., Ltd
K182286 08/23/2018 Oh'Care Lite Smart Blood Glucose Monitoring System OSANG Healthcare Co., Ltd.
K142290 08/18/2014 KangLi pedical screw spinal system SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD
K212137 07/08/2021 X-Clever LG Electronics.Inc
K220532 02/24/2022 Disposable surgical mask Xiamen Blue Star Enterprise Co., Ltd.
K230456 02/21/2023 SGM Femoral Nail System Changzhou Geasure Medical Apparatus and Instruments Co., Ltd
K222031 07/11/2022 Spinal Inner Fixation System Changzhou Geasure Medical Apparatus and Instruments Co., Ltd
K223776 12/16/2022 PEEK Spinal Infusion Cage Changzhou Geasure Medical Apparatus and Instruments Co., Ltd
K162234 08/09/2016 Truscope Ultra Patient Monitor GUANGDONG BIOLIGHT MEDITECH CO., LTD.
K152739 09/23/2015 Electronic Thermometer GUANGDONG BIOLIGHT MEDITECH CO., LTD
K160341 02/08/2016 Colposcope System XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD
K200971 04/13/2020 308nm Excimer System Xuzhou Kernel Medical Equipment Co., Ltd.
K181805 07/06/2018 UV Phototherapy Xuzhou Kernel Medical Equipment Co., LTD.
K212726 08/27/2021 Disposable Medical Surgical Mask Hubei Huaqiang High-Tech Co., Ltd.
K010099 01/11/2001 ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER ZCV ,INC.
K960635 02/14/1996 PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC.
K970734 02/28/1997 SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC.
DEN050003 02/28/2005 PAXGENE BLOOD RNA SYSTEM PREANALYTIX GMBH
K971054 03/24/1997 OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC.
K041071 04/26/2004 BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 BECTON DICKINSON & CO.
K971717 05/09/1997 FLY THROUGH SIEMENS MEDICAL SOLUTIONS USA, INC.
K011847 06/13/2001 ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE ZYNERGY CARDIO VASULAR (ZCV), INC.
K022130 07/01/2002 BD VACUTAINER PLUS PST II TUBE BECTON DICKINSON & CO.
K002481 08/14/2000 ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3 ZCV ,INC.
K002603 08/22/2000 ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER ZCV ,INC.
K152415 08/26/2015 Digital Blood Pressure Monitor SUZHOU SUNSPIRIT CO., LTD.
K992885 08/27/1999 VERSALOK LOW BACK FIXATION SYSTEM OSTEOTECH, INC.
K002687 08/29/2000 ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3 ZYNERGY CARDIOVASCULAR, INC.
K023075 09/16/2002 BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS
K023331 10/04/2002 BD VACUTAINER SST II PLUS TUBES BECTON DICKINSON & CO.
K003118 10/05/2000 Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 ZCV ,INC.
K153033 10/19/2015 Digital Blood Pressure Monitor SUZHOU SUNSPIRI CO., LTD.
K974083 10/29/1997 CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS OHMEDA MEDICAL
K974374 11/20/1997 SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV OHMEDA MEDICAL
K965004 12/16/1996 C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER SIEMENS MEDICAL SOLUTIONS USA, INC.
K024240 12/23/2002 BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS BD
K222710 09/08/2022 IPL Cooling Hair Removal Device Shenzhen Siken 3D Technology Development Co., Ltd.
K210189 01/25/2021 Pac-Dent Denture Base Resin Pac-Dent, Inc.
K210412 02/11/2021 Pac-Dent Ceramic Nanohybrid Resin Pac-Dent, Inc.
K223365 11/03/2022 RODIN Palette Naturalizing Kit Belport Company, Inc., Gingi-Pak
K210909 03/29/2021 easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use Ezisurg Medical Co., Ltd.
K182217 08/15/2018 Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use Ezisurg (Suzhou) Medical Co., Ltd.
K182495 09/11/2018 Electronic Blood Pressure Monitor Shenzhen Jumper Medical Equipment Co., Ltd.
K180332 02/06/2018 17HK700G-W LG Electronics
K220559 02/28/2022 17HQ901G-B LG Electronics Inc.
K170899 03/27/2017 27HJ713S LG Electronics
K230845 03/28/2023 32HL512D, 31HN713D, 32HQ713D LG Electronics Inc.
K221061 04/11/2022 21HQ613D LG Electronics Inc.
K191188 05/03/2019 ASHK100G LG Electronics
K221394 05/13/2022 14HQ701G-B LG Electronics Inc.
K221434 05/17/2022 17HQ701G-B LG Electronics Inc.
K221461 05/19/2022 10HQ701G-B LG Electronics Inc.
K201777 06/29/2020 31HN713D LG Electronics Inc.
K191864 07/12/2019 21HK512D LG Electronics Inc.
K212295 07/22/2021 21HQ513D LG Electronics Inc.
K182348 08/29/2018 14HK701G-W LG Electronics Inc.
K192925 10/16/2019 32HL512D LG Electronics Inc.
K223423 11/14/2022 32HQ713D LG Electronics Inc.
K223546 11/25/2022 14HQ721G-B LG Electronics Inc.
K183286 11/26/2018 17HK701G-W LG Electronics Inc.
K223789 12/19/2022 21HQ513D LG Electronics Inc.
K214044 12/27/2021 14HQ901G-B LG Electronics Inc.
K160615 03/03/2016 ORTHODONTIC CERAMIC BRACKETS 1.1 TOMY, INC
K180718 03/19/2018 ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES TOMY, Inc.
K211583 05/24/2021 Infrared Thermometer, Model: HW-1 Dongguan SIMZO Electronic Technology Co.Ltd.
K202670 09/14/2020 Nam illumination probe with chopper Oculight Ltd.
K063295 11/01/2006 ACON UTI URINARY TRACT INFECTION TEST STRIPS ACON LABORATORIES, INC.
K063418 11/13/2006 ACON DIGITAL THERMOMETER PROBE COVERS ACON LABORATORIES, INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact