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 |