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FDA 510(k)

SD5 & SD6 Ultrasonic Tabletop Doppler

K-Number: K153475 · 2016-01-29

ApplicantEdan Instruments, Inc.
Decision Date2016-01-29
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SD5 & SD6 Ultrasonic Tabletop Doppler is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2016-01-29 under approval number K153475. 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 SD5 & SD6 Ultrasonic Tabletop Doppler?

SD5 & SD6 Ultrasonic Tabletop Doppler is a medical device that received FDA 510(k) clearance on 2016-01-29. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K153475.

When was SD5 & SD6 Ultrasonic Tabletop Doppler approved by the FDA?

SD5 & SD6 Ultrasonic Tabletop Doppler received FDA 510(k) clearance on 2016-01-29, under approval number K153475.

What company makes SD5 & SD6 Ultrasonic Tabletop Doppler?

SD5 & SD6 Ultrasonic Tabletop Doppler is manufactured by Edan Instruments, Inc..

What is the FDA product code for SD5 & SD6 Ultrasonic Tabletop Doppler?

The FDA product code for SD5 & SD6 Ultrasonic Tabletop Doppler is KNG.

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Related Devices (Code: KNG)

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 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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