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FDA 510(k)

Fetal Doppler

K-Number: K182190 · 2018-12-19

ApplicantShenzhen AOJ Medical Technology Co., Ltd.
Decision Date2018-12-19
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Fetal Doppler is a medical device manufactured by Shenzhen AOJ Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-12-19 under approval number K182190. The device is classified under product code KNG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fetal Doppler?

Fetal Doppler is a medical device that received FDA 510(k) clearance on 2018-12-19. It is manufactured by Shenzhen AOJ Medical Technology Co., Ltd.. The 510(k) number is K182190.

When was Fetal Doppler approved by the FDA?

Fetal Doppler received FDA 510(k) clearance on 2018-12-19, under approval number K182190.

What company makes Fetal Doppler?

Fetal Doppler is manufactured by Shenzhen AOJ Medical Technology Co., Ltd..

What is the FDA product code for Fetal Doppler?

The FDA product code for Fetal Doppler is KNG.

Related Clinical Trials

NCT06861309 Placental Imaging Techniques RECRUITING NCT01400880 Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability COMPLETED

Other Devices by Shenzhen AOJ Medical Technology Co., Ltd.

K182133Infrared Thermometer K191180Electronic Blood Pressure Monitor K202173Pulse Oximeter K221039Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y K222125Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G K221170Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107

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Related Devices (Code: KNG)

K153475SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc. K180419Ultrasonic Doppler (Model YM-2T8)Shenzhen Imdk Medical Technology Co., Ltd. K172780SD1 Ultrasonic Pocket DopplerEdan Instruments, Inc. K191110HeraBEAT™ USHeramed, Ltd. K182526Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)Vcomin Technology Limited K182710Fetal Doppler, Model FD88Shenzzhen Luckcome Technology Inc., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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