FDA 510(k)

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

N.º K: K232893 · 2024-06-14

SolicitanteContec Medical Systems Co.,Ltd

Fecha de decisión2024-06-14

Código de productoKNG

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) is the device name listed in this FDA 510(k) record. The listed applicant is Contec Medical Systems Co.,Ltd. It received FDA 510(k) clearance on 2024-06-14 under 510(k) number K232893. The device is classified under product code KNG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)?

Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Contec Medical Systems Co.,Ltd. The 510(k) number is K232893.

When did Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) receive FDA 510(k) clearance?

Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) received FDA 510(k) clearance on 2024-06-14, under 510(k) number K232893.

Who is the listed applicant for Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)?

The FDA 510(k) record lists Contec Medical Systems Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)?

The FDA product code for Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) is KNG.

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Otros registros que enlistan a Contec Medical Systems Co.,Ltd como solicitante

K232895B-Ultrasound Diagnostic System K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)K202757CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor K201980Infrared Thermometer K171360CONTEC™ Electrocardiograph

Ver todos los 10 dispositivos →

Dispositivos relacionados (Código: KNG)

K252669Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic Factory K242846Doppler FHR Detector (BF-500D+, BF-560)Shenzhen Bestman Instrument Co., Ltd.K233823Ultrasonic Fetal DopplerShenzhen Jamr Technology Co., Ltd.K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,Ltd K211940Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd.K212084Fetal DopplerShenzhen Mericonn Technology Co., Ltd.

Fuente oficial

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