FDA Product Code
FDA Product Code KNG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.2660
510(k) Clearances — 60 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252669 | Fetal Doppler U8-25, U9-25 | Zhongshan Xiaolan Town Senlan Electronic Factory | 2026-01-08 | Traditional | PDF ↗ |
| K242846 | Doppler FHR Detector (BF-500D+, BF-560) | Shenzhen Bestman Instrument Co., Ltd. | 2025-06-26 | Traditional | PDF ↗ |
| K233823 | Ultrasonic Fetal Doppler | Shenzhen Jamr Technology Co., Ltd. | 2024-06-28 | Traditional | PDF ↗ |
| K232893 | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) | Contec Medical Systems Co.,Ltd | 2024-06-14 | Traditional | PDF ↗ |
| K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) | Contec Medical Systems Co.,Ltd | 2022-09-28 | Traditional | PDF ↗ |
| K211940 | Fetal Doppler | Shenzhen Taikang Medical Equipment Co., Ltd. | 2022-01-07 | Traditional | PDF ↗ |
| K212084 | Fetal Doppler | Shenzhen Mericonn Technology Co., Ltd. | 2021-11-03 | Traditional | PDF ↗ |
| K191110 | HeraBEAT US | Heramed, Ltd. | 2019-11-14 | Traditional | PDF ↗ |
| K182526 | Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) | Vcomin Technology Limited | 2019-05-29 | Traditional | PDF ↗ |
| K182710 | Fetal Doppler, Model FD88 | Shenzzhen Luckcome Technology Inc., Ltd. | 2019-03-01 | Traditional | PDF ↗ |
| K182190 | Fetal Doppler | Shenzhen AOJ Medical Technology Co., Ltd. | 2018-12-19 | Traditional | PDF ↗ |
| K180419 | Ultrasonic Doppler (Model YM-2T8) | Shenzhen Imdk Medical Technology Co., Ltd. | 2018-07-19 | Traditional | PDF ↗ |
| K172780 | SD1 Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2018-06-06 | Traditional | PDF ↗ |
| K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler | Edan Instruments, Inc. | 2016-01-29 | Traditional | PDF ↗ |
| K140579 | ULTRASONIC POCKET DOPPLER | Edan Instruments, Inc. | 2015-02-06 | Traditional | PDF ↗ |
| K131457 | FETAL ULTRASONIC MONITOR AND ACCESSORIES | Shenzhen Jumper Medical Equipment Co., Ltd. | 2014-01-24 | Traditional | PDF ↗ |
| K112529 | TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER | Advanced Instrumentations, Inc. | 2011-10-27 | Traditional | PDF ↗ |
| K112911 | FETAL DOPPLER | Beijing Choice Electronic Technololgy Co., Ltd. | 2011-10-27 | Traditional | PDF ↗ |
| K111934 | PD-100 SERIES ULTRASONIC POCKET DOPPLER | Advanced Instrumentations, Inc. | 2011-09-22 | Traditional | PDF ↗ |
| K110630 | F10 | Mediana Co., Ltd. | 2011-06-24 | Traditional | PDF ↗ |
| K110124 | FETAL DOPPLER JPD-100S | Shenzhen Jumper Medical Equipment Co., Ltd. | 2011-02-04 | Traditional | PDF ↗ |
| K100626 | DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 | Shenzhen Biocare Electronics Co., Ltd. | 2010-05-21 | Traditional | PDF ↗ |
| K090510 | DOPPLER FETAL HEARTBEAT RATE DETECTOR | Shenzhen Bestman Instrument Co., Ltd. | 2010-04-29 | Traditional | PDF ↗ |
| K092997 | ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 | Edan Instruments, Inc. | 2009-11-10 | Traditional | PDF ↗ |
| K082480 | CONTEC POCKET FETAL DOPPLER | Contec Medical System Co., Ltd. | 2009-02-25 | Traditional | PDF ↗ |
| K082055 | MODEL PC-860 FETAL DOPPLER | Shenzhen Creative Industry Co., Ltd. | 2009-02-06 | Traditional | PDF ↗ |
| K080087 | SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR | Edan Instruments, Inc. | 2008-03-11 | Traditional | PDF ↗ |
| K061091 | BABYBEAT CORDLESS | The Newman Group, LLC | 2006-05-04 | Traditional | PDF ↗ |
| K040480 | SONOTRAX ULTRASONIC POCKET DOPPLER | Edan Instruments, Inc. | 2004-05-25 | Traditional | PDF ↗ |
| K033156 | OB1 OBSTETRICAL DOPPLER | D. E. Hokanson, Inc. | 2003-12-09 | Traditional | PDF ↗ |
| K030466 | HANDYDOP | Elcat, GmbH | 2003-09-12 | Abbreviated | PDF ↗ |
| K031504 | ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX | Koven Technology, Inc. | 2003-07-18 | Traditional | PDF ↗ |
| K024197 | LIFEDOP DOPPLER | Summit Doppler Systems, Inc. | 2003-01-03 | Traditional | PDF ↗ |
| K023143 | ECHO SOUNDER, ES-102EX | Koven Technology, Inc. | 2002-12-19 | Traditional | PDF ↗ |
| K013547 | BABYCOM | Pmg Medica , Ltd. | 2002-02-20 | Traditional | PDF ↗ |
| K991441 | CADENCE DOPPLER ULTRASOUND SYSTEM | Medasonics, Inc. | 1999-12-28 | Traditional | PDF ↗ |
| K930200 | MULTI DOPPLEX II / FETAL DOPPLEX II | Huntleigh Healthcare, Inc. | 1994-06-24 | Traditional | PDF ↗ |
| K920056 | POCKET SIZE FETAL HEART DETECTOR | Medical Accessories, Inc. | 1992-12-11 | Traditional | PDF ↗ |
| K911453 | OBTRASOUND STETHOSCOPE FETAL CALC | Medasonics, Inc. | 1991-06-20 | Traditional | PDF ↗ |
| K910153 | UST-974-5 CONVEX TRANSDUCER | Ge Medical Systems Information Technologies | 1991-03-29 | Traditional | PDF ↗ |
| K901593 | IMEX DOP-TONE II | Imex Medical Systems, Inc. | 1990-07-02 | Traditional | PDF ↗ |
| K900618 | HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140 | Huntleigh Technology, Inc. | 1990-04-25 | Traditional | PDF ↗ |
| K890139 | TOITU DOPPLER FETUS DETECTOR, FD-400D | Toitu of America, Inc. | 1989-03-29 | Traditional | PDF ↗ |
| K870653 | ULTRASOUND LINEAR/SECTOR SCANNER 1100 | Pie Data Medical BV | 1988-02-02 | Traditional | PDF ↗ |
| K870058 | PIE MEDICAL SCANNER 1000 | Pie Data Medical BV | 1988-02-02 | Traditional | PDF ↗ |
| K854267 | HUNTLEIGH DOPCORD, D140 | Huntleigh Technology, Inc. | 1986-07-09 | Traditional | PDF ↗ |
| K852655 | COMBISCOPE | Instrument Technology, Inc. | 1986-02-21 | Traditional | PDF ↗ |
| K841805 | OBSTETRICAL DOPPLER | Epcom Medical Systems, Inc. | 1984-06-19 | Traditional | PDF ↗ |
| K823242 | PROGRAMALITH PROGRAMMER | Pacesetter Systems | 1983-01-08 | Traditional | PDF ↗ |
| K812868 | FETAL PULSE DETECTORS, F50/F60 | South Carolina Medical, Inc. | 1981-11-25 | Traditional | PDF ↗ |
| K810115 | DOPPLEX-PLB & PXB | Huntleigh Technology, Inc. | 1981-07-16 | Traditional | PDF ↗ |
| K802024 | GRAVIDAPHONE | Solar Electronics | 1981-01-07 | Traditional | PDF ↗ |
| K800859 | FETAL HEART DETECTOR #D206 | Sonicaid, Inc. | 1980-05-14 | Traditional | PDF ↗ |
| K800858 | FETAL HEART DETECTOR #'S D102 & D102R | Sonicaid, Inc. | 1980-05-14 | Traditional | PDF ↗ |
| K800098 | MINIFETON 200 | Kt Medical, Inc. | 1980-02-11 | Traditional | PDF ↗ |
| K800095 | MGD-3 | Kt Medical, Inc. | 1980-02-11 | Traditional | PDF ↗ |
| K790951 | SA/7860 FETAL HEART MONITOR (DOPPLER) | Schlosser Alberti Co. | 1979-08-03 | Traditional | PDF ↗ |
| K770904 | PROBE, BLOOD FLOW DETECTOR PLUG-IN | Medsonics | 1977-05-26 | Traditional | PDF ↗ |
| K760888 | MODEL 6/60 CRT VIDEO-SONAR | Vexilar, Inc. | 1977-02-01 | Traditional | PDF ↗ |
| K760728 | CONTINUOUS WAVE DOPPLER ULTRASOUND | Medsonics | 1976-10-06 | Traditional | PDF ↗ |
Product code KNG · Class II · Obstetrics/Gynecology. Data: openFDA.