Monitor, Ultrasonic, Fetal

FDA product code KNG · 58 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.2660
Review panel: OB
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-10-06 – 2026-01-08

KNG 2026-01-08

Fetal Doppler U8-25, U9-25

Applicant Zhongshan Xiaolan Town Senlan Electronic Factory

K number K252669

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KNG 2025-06-26

Doppler FHR Detector (BF-500D+, BF-560)

Applicant Shenzhen Bestman Instrument Co., Ltd.

K number K242846

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KNG 2024-06-28

Ultrasonic Fetal Doppler

Applicant Shenzhen Jamr Technology Co., Ltd.

K number K233823

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KNG 2024-06-14

Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)

Applicant Contec Medical Systems Co.,Ltd

K number K232893

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KNG 2022-09-28

Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)

Applicant Contec Medical Systems Co.,Ltd

K number K220245

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KNG 2022-01-07

Fetal Doppler

Applicant Shenzhen Taikang Medical Equipment Co., Ltd.

K number K211940

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KNG 2021-11-03

Fetal Doppler

Applicant Shenzhen Mericonn Technology Co., Ltd.

K number K212084

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KNG 2019-11-14

HeraBEAT™ US

Applicant Heramed, Ltd.

K number K191110

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KNG 2019-05-29

Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)

Applicant Vcomin Technology Limited

K number K182526

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KNG 2019-03-01

Fetal Doppler, Model FD88

Applicant Shenzzhen Luckcome Technology Inc., Ltd.

K number K182710

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KNG 2018-12-19

Fetal Doppler

Applicant Shenzhen AOJ Medical Technology Co., Ltd.

K number K182190

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KNG 2018-07-19

Ultrasonic Doppler (Model YM-2T8)

Applicant Shenzhen Imdk Medical Technology Co., Ltd.

K number K180419

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KNG 2018-06-06

SD1 Ultrasonic Pocket Doppler

Applicant Edan Instruments, Inc.

K number K172780

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KNG 2016-01-29

SD5 & SD6 Ultrasonic Tabletop Doppler

Applicant Edan Instruments, Inc.

K number K153475

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KNG 2011-10-27

FETAL DOPPLER

Applicant Beijing Choice Electronic Technololgy Co., Ltd.

K number K112911

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KNG 2011-10-27

TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER

Applicant Advanced Instrumentations, Inc.

K number K112529

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KNG 2011-09-22

PD-100 SERIES ULTRASONIC POCKET DOPPLER

Applicant Advanced Instrumentations, Inc.

K number K111934

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KNG 2011-06-24

F10

Applicant Mediana Co., Ltd.

K number K110630

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KNG 2011-02-04

FETAL DOPPLER JPD-100S

Applicant Shenzhen Jumper Medical Equipment Co., Ltd.

K number K110124

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KNG 2010-05-21

DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200

Applicant Shenzhen Biocare Electronics Co., Ltd.

K number K100626

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KNG 2010-04-29

DOPPLER FETAL HEARTBEAT RATE DETECTOR

Applicant Shenzhen Bestman Instrument Co., Ltd.

K number K090510

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KNG 2009-11-10

ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6

Applicant Edan Instruments, Inc.

K number K092997

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KNG 2009-02-25

CONTEC POCKET FETAL DOPPLER

Applicant Contec Medical System Co., Ltd.

K number K082480

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KNG 2009-02-06

MODEL PC-860 FETAL DOPPLER

Applicant Shenzhen Creative Industry Co., Ltd.

K number K082055

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KNG 2008-03-11

SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR

Applicant Edan Instruments, Inc.

K number K080087

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KNG 2006-05-04

BABYBEAT CORDLESS

Applicant The Newman Group, LLC

K number K061091

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KNG 2004-05-25

SONOTRAX ULTRASONIC POCKET DOPPLER

Applicant Edan Instruments, Inc.

K number K040480

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KNG 2003-12-09

OB1 OBSTETRICAL DOPPLER

Applicant D. E. Hokanson, Inc.

K number K033156

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KNG 2003-09-12

HANDYDOP

Applicant Elcat, GmbH

K number K030466

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KNG 2003-07-18

ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX

Applicant Koven Technology, Inc.

K number K031504

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KNG 2003-01-03

LIFEDOP DOPPLER

Applicant Summit Doppler Systems, Inc.

K number K024197

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KNG 2002-12-19

ECHO SOUNDER, ES-102EX

Applicant Koven Technology, Inc.

K number K023143

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KNG 2002-02-20

BABYCOM

Applicant Pmg Medica , Ltd.

K number K013547

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KNG 1999-12-28

CADENCE DOPPLER ULTRASOUND SYSTEM

Applicant Medasonics, Inc.

K number K991441

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KNG 1994-06-24

MULTI DOPPLEX II / FETAL DOPPLEX II

Applicant Huntleigh Healthcare, Inc.

K number K930200

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KNG 1992-12-11

POCKET SIZE FETAL HEART DETECTOR

Applicant Medical Accessories, Inc.

K number K920056

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KNG 1991-06-20

OBTRASOUND STETHOSCOPE FETAL CALC

Applicant Medasonics, Inc.

K number K911453

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KNG 1991-03-29

UST-974-5 CONVEX TRANSDUCER

Applicant Ge Medical Systems Information Technologies

K number K910153

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KNG 1990-07-02

IMEX DOP-TONE II

Applicant Imex Medical Systems, Inc.

K number K901593

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KNG 1990-04-25

HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140

Applicant Huntleigh Technology, Inc.

K number K900618

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KNG 1989-03-29

TOITU DOPPLER FETUS DETECTOR, FD-400D

Applicant Toitu of America, Inc.

K number K890139

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KNG 1988-02-02

ULTRASOUND LINEAR/SECTOR SCANNER 1100

Applicant Pie Data Medical BV

K number K870653

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KNG 1988-02-02

PIE MEDICAL SCANNER 1000

Applicant Pie Data Medical BV

K number K870058

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KNG 1986-07-09

HUNTLEIGH DOPCORD, D140

Applicant Huntleigh Technology, Inc.

K number K854267

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KNG 1986-02-21

COMBISCOPE

Applicant Instrument Technology, Inc.

K number K852655

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KNG 1984-06-19

OBSTETRICAL DOPPLER

Applicant Epcom Medical Systems, Inc.

K number K841805

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KNG 1983-01-08

PROGRAMALITH PROGRAMMER

Applicant Pacesetter Systems

K number K823242

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KNG 1981-11-25

FETAL PULSE DETECTORS, F50/F60

Applicant South Carolina Medical, Inc.

K number K812868

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KNG 1981-07-16

DOPPLEX-PLB & PXB

Applicant Huntleigh Technology, Inc.

K number K810115

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KNG 1981-01-07

GRAVIDAPHONE

Applicant Solar Electronics

K number K802024

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KNG 1980-05-14

FETAL HEART DETECTOR #D206

Applicant Sonicaid, Inc.

K number K800859

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KNG 1980-05-14

FETAL HEART DETECTOR #'S D102 & D102R

Applicant Sonicaid, Inc.

K number K800858

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KNG 1980-02-11

MINIFETON 200

Applicant Kt Medical, Inc.

K number K800098

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KNG 1980-02-11

MGD-3

Applicant Kt Medical, Inc.

K number K800095

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KNG 1979-08-03

SA/7860 FETAL HEART MONITOR (DOPPLER)

Applicant Schlosser Alberti Co.

K number K790951

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KNG 1977-05-26

PROBE, BLOOD FLOW DETECTOR PLUG-IN

Applicant Medsonics

K number K770904

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KNG 1977-02-01

MODEL 6/60 CRT VIDEO-SONAR

Applicant Vexilar, Inc.

K number K760888

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KNG 1976-10-06

CONTINUOUS WAVE DOPPLER ULTRASOUND

Applicant Medsonics

K number K760728

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