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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 the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2016-01-29 under 510(k) 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. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K153475.

When did SD5 & SD6 Ultrasonic Tabletop Doppler receive FDA 510(k) clearance?

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

Who is the listed applicant for SD5 & SD6 Ultrasonic Tabletop Doppler?

The FDA 510(k) record lists Edan Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Edan Instruments, Inc. as applicant

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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

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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