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FDA 510(k)

SD1 Ultrasonic Pocket Doppler

K-Number: K172780 · 2018-06-06

ApplicantEdan Instruments, Inc.
Decision Date2018-06-06
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SD1 Ultrasonic Pocket Doppler is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2018-06-06 under approval number K172780. 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 SD1 Ultrasonic Pocket Doppler?

SD1 Ultrasonic Pocket Doppler is a medical device that received FDA 510(k) clearance on 2018-06-06. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K172780.

When was SD1 Ultrasonic Pocket Doppler approved by the FDA?

SD1 Ultrasonic Pocket Doppler received FDA 510(k) clearance on 2018-06-06, under approval number K172780.

What company makes SD1 Ultrasonic Pocket Doppler?

SD1 Ultrasonic Pocket Doppler is manufactured by Edan Instruments, Inc..

What is the FDA product code for SD1 Ultrasonic Pocket Doppler?

The FDA product code for SD1 Ultrasonic Pocket Doppler is KNG.

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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. 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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