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 |
| K232893 | Contec Medical Systems Co., Ltd. | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) | 06/14/2024 |
| 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 |
| K242846 | Shenzhen Bestman Instrument Co., Ltd. | Doppler FHR Detector (BF-500D+, BF-560) | 06/26/2025 |
| 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 |
| K233823 | Shenzhen Jamr Technology Co., Ltd. | Ultrasonic Fetal Doppler | 06/28/2024 |
| 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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