FDA 510(k) Applications for Medical Device Product Code "KNG"
(Monitor, Ultrasonic, Fetal)

FDA 510(k) Number Applicant Device Name Decision Date
K111934 ADVANCED INSTRUMENTATIONS, INC. PD-100 SERIES ULTRASONIC POCKET DOPPLER 09/22/2011
K112529 ADVANCED INSTRUMENTATIONS, INC. TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER 10/27/2011
K112911 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. FETAL DOPPLER 10/27/2011
K082480 CONTEC MEDICAL SYSTEM CO., LTD. CONTEC POCKET FETAL DOPPLER 02/25/2009
K220245 Contec Medical Systems Co., Ltd. Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) 09/28/2022
K033156 D. E. HOKANSON, INC. OB1 OBSTETRICAL DOPPLER 12/09/2003
K172780 Edan Instruments Inc SD1 Ultrasonic Pocket Doppler 06/06/2018
K153475 EDAN INSTRUMENTS, INC. SD5 & SD6 Ultrasonic Tabletop Doppler 01/29/2016
K080087 EDAN INSTRUMENTS, INC. SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR 03/11/2008
K040480 EDAN INSTRUMENTS, INC. SONOTRAX ULTRASONIC POCKET DOPPLER 05/25/2004
K140579 EDAN INSTRUMENTS, INC. ULTRASONIC POCKET DOPPLER 02/06/2015
K092997 EDAN INSTRUMENTS, INC. ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 11/10/2009
K030466 ELCAT, GMBH HANDYDOP 09/12/2003
K191110 HeraMED Ltd. HeraBEATÖ US 11/14/2019
K023143 KOVEN TECHNOLOGY, INC. ECHO SOUNDER, ES-102EX 12/19/2002
K031504 KOVEN TECHNOLOGY, INC. ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX 07/18/2003
K991441 MEDASONICS, INC. CADENCE DOPPLER ULTRASOUND SYSTEM 12/28/1999
K110630 MEDIANA CO., LTD. F10 06/24/2011
K013547 PMG MEDICA LTD. BABYCOM 02/20/2002
K182190 Shenzhen AOJ Medical Technology Co., Ltd. Fetal Doppler 12/19/2018
K090510 SHENZHEN BESTMAN INSTRUMENT CO., LTD. DOPPLER FETAL HEARTBEAT RATE DETECTOR 04/29/2010
K100626 SHENZHEN BIOCARE ELECTRONICS CO., LTD DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 05/21/2010
K082055 SHENZHEN CREATIVE INDUSTRY CO., LTD MODEL PC-860 FETAL DOPPLER 02/06/2009
K180419 Shenzhen IMDK Medical Technology Co., Ltd. Ultrasonic Doppler (Model YM-2T8) 07/19/2018
K110124 SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD FETAL DOPPLER JPD-100S 02/04/2011
K131457 SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD FETAL ULTRASONIC MONITOR AND ACCESSORIES 01/24/2014
K212084 Shenzhen Mericonn Technology Co., Ltd. Fetal Doppler 11/03/2021
K211940 Shenzhen Taikang Medical Equipment Co., Ltd. Fetal Doppler 01/07/2022
K182710 ShenzZhen Luckcome Technology Inc., Ltd. Fetal Doppler, Model FD88 03/01/2019
K024197 SUMMIT DOPPLER SYSTEMS, INC. LIFEDOP DOPPLER 01/03/2003
K061091 THE NEWMAN GROUP, LLC BABYBEAT CORDLESS 05/04/2006
K182526 Vcomin Technology Limited Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) 05/29/2019


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