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FDA 510(k)

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

K-Number: K232893 · 2024-06-14

ApplicantContec Medical Systems Co.,Ltd
Decision Date2024-06-14
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

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

When was Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) approved by the FDA?

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 approval number K232893.

What company makes 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 manufactured by Contec Medical Systems Co.,Ltd.

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.

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 Contec Medical Systems Co.,Ltd

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Related Devices (Code: KNG)

K153475SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc. K182190Fetal DopplerShenzhen AOJ Medical Technology Co., Ltd. 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

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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