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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzzhen Luckcome Technology Inc., Ltd.. It received FDA 510(k) clearance on 2019-03-01 under 510(k) 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. The listed applicant is Shenzzhen Luckcome Technology Inc., Ltd.. The 510(k) number is K182710.

When did Fetal Doppler, Model FD88 receive FDA 510(k) clearance?

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

Who is the listed applicant for Fetal Doppler, Model FD88?

The FDA 510(k) record lists Shenzzhen Luckcome Technology Inc., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: KNG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252669Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic FactoryK242846Doppler FHR Detector (BF-500D+, BF-560)Shenzhen Bestman Instrument Co., Ltd.K233823Ultrasonic Fetal DopplerShenzhen Jamr Technology Co., Ltd.K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)Contec Medical Systems Co.,LtdK220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,LtdK211940Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd.

Official Source

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

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