Monitor, Ultrasonic, Fetal

Product Code: KNG

Obstetrics/Gynecology Diagnostic Ultrasound Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 884.2660


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as KNG

3999Monitor, Ultrasonic, FetalFetal Ultrasonic Monitor And Accessories.

Total Product Life Cycle (TPLC) Devices

3999Monitor, Ultrasonic, FetalFetal Ultrasonic Monitor And Accessories.

Pre-market Notifications for KNG

K220245Pocket Fetal Doppler (Models CONTEC10C And CONTEC10CL)Contec Medical Systems Co., Ltd.
K212084Fetal DopplerShenzhen Mericonn Technology Co., Ltd.
K211940Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd.
K191110HeraBEAT™ USHeraMED Ltd.
K182710Fetal Doppler, Model FD88ShenzZhen Luckcome Technology Inc., Ltd.
K182526Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, And FD-591D)Vcomin Technology Limited
K182190Fetal DopplerShenzhen AOJ Medical Technology Co., Ltd.
K180419Ultrasonic Doppler (Model YM-2T8)Shenzhen IMDK Medical Technology Co., Ltd.
K172780SD1 Ultrasonic Pocket DopplerEdan Instruments Inc
K153475SD5 & SD6 Ultrasonic Tabletop DopplerEDAN INSTRUMENTS, INC.
K140579ULTRASONIC POCKET DOPPLEREDAN INSTRUMENTS, INC.
K131457FETAL ULTRASONIC MONITOR AND ACCESSORIESSHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
K112911FETAL DOPPLERBEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
K112529TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLERADVANCED INSTRUMENTATIONS, INC.
K111934PD-100 SERIES ULTRASONIC POCKET DOPPLERADVANCED INSTRUMENTATIONS, INC.

Global Unique Device Identification Database

00382830028271Monitor, Ultrasonic, Fetal
00382830028264Monitor, Ultrasonic, Fetal
00382830028257Monitor, Ultrasonic, Fetal
00382830028240Monitor, Ultrasonic, Fetal
00382830028073Monitor, Ultrasonic, Fetal
00628055787266Monitor, Ultrasonic, Fetal
00628055787051Monitor, Ultrasonic, Fetal
00628055787013Monitor, Ultrasonic, Fetal
00815871020381Monitor, Ultrasonic, Fetal
00815871020374Monitor, Ultrasonic, Fetal
00866755000289Monitor, Ultrasonic, Fetal
00864243000414Monitor, Ultrasonic, Fetal
10861910000309Monitor, Ultrasonic, Fetal
00854878007070Monitor, Ultrasonic, Fetal
00851908007161Monitor, Ultrasonic, Fetal

Maude Adverse Events

BABYDOPPLER SONOLINE BDAGAMMA, INC.2019-10-11
BABYDOPPLERCONTEC MEDICAL SYSTEMS2018-09-18
BABYDOPPLER SONOLINEUNK2018-08-06
BABY DOPPLERBABYDOPPLER/DOGAMMA INC.2018-05-03
BABY DOPPLERDAGAMMA INC.2018-05-03
WOMB MUSIC HEARTBEAT MONITORSHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD.2018-04-25
SONOLINE B HEARTBEAT MONITORCONTEC MEDICAL SYSTEMS CO., LTD.2018-04-25
FACELAKE FL-100B HEARTBEAT BABY MONITOR SOUND LISTENING TOOLCONTEC MEDICAL SYSTEM2018-04-13
CONTEC POCKET FETAL DOPPLERCONTEC MEDICAL SYSTEM CO. LTD.2018-04-11
SONOLOINE B HEARTBEAT MONITOR BY BABYDOPPLERCONTEC MEDICAL SYSTEMS CO. LTD.2018-03-19
BABYDOPPLER SONOLINESUMMIT DOPPLER SYSTEMS, INC.2018-02-15
BABYDOPPLER SONOLINEDAGAMMA INC.2018-02-15
SONOLINE B HEARTBEAT MONITOR BY BABYDOPPLERUNK2018-02-09
SONOLINEUNK2017-12-01
SONOLINEDAGAMMA INC.2017-11-28
SONOLINE BCONTEC MEDICAL SYSTEMS2017-11-22
AVALON FM50PHILLIPS2014-08-15
FETAL DOPPLERSHENZHEN JUMPER MEDICAL EQUIPM2013-09-09
CRE ESOPHGEAL/PYLORIC/COLONIC WIREGUIDED BALLOON DILATION CATHETERBOSTON SCIENTIFIC2008-09-12
C.R.E. BALLOON DILATION CATHETERBOSTON SCIENTIFIC2008-06-09
V4 4FB QUIKTRAKBHM MEDICAL, INC.2005-03-04
COROMETRICSGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES2003-12-31
GE MEDICAL SYSTEMS, ITGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES2003-03-14
COROMETRICSCOROMETRICS1997-03-31
AQUASONIC 100 ULTRASOUND TRANSMISSION GELPARKER LABORATORIES, INC.1996-11-04
NATURAL IMAGE ULTRASOUND SCANNING GELACCUPAC, INC.1994-02-22
ULTRASOUND GELE-Z EM CO.1994-02-07
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