Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Fetal Doppler, Model FD88

K-Number: K182710 · 2019-03-01

ApplicantShenzzhen Luckcome Technology Inc., Ltd.
Decision Date2019-03-01
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Fetal Doppler, Model FD88 is a medical device manufactured by Shenzzhen Luckcome Technology Inc., Ltd.. It received FDA 510(k) clearance on 2019-03-01 under approval number K182710. 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, Model FD88?

Fetal Doppler, Model FD88 is a medical device that received FDA 510(k) clearance on 2019-03-01. It is manufactured by Shenzzhen Luckcome Technology Inc., Ltd.. The 510(k) number is K182710.

When was Fetal Doppler, Model FD88 approved by the FDA?

Fetal Doppler, Model FD88 received FDA 510(k) clearance on 2019-03-01, under approval number K182710.

What company makes Fetal Doppler, Model FD88?

Fetal Doppler, Model FD88 is manufactured by Shenzzhen Luckcome Technology Inc., Ltd..

What is the FDA product code for Fetal Doppler, Model FD88?

The FDA product code for Fetal Doppler, Model FD88 is KNG.

Related Clinical Trials

NCT06861309 Placental Imaging Techniques RECRUITING NCT07409545 Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes NOT_YET_RECRUITING NCT07539727 Clinical Value of Intestinal Ultrasound in Predicting Clinical Relapse in Crohn's Disease Patients in Deep Remission: a Multicenter Prospective Observational Study RECRUITING NCT01400880 Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability COMPLETED

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.

↑