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FDA 510(k)

Transcranial Doppler Ultrasound System

K-Number: K213009 · 2022-07-08

ApplicantShenzhen Delica Medical Equipment Co., Ltd.
Decision Date2022-07-08
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Transcranial Doppler Ultrasound System is a medical device manufactured by Shenzhen Delica Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-07-08 under approval number K213009. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Transcranial Doppler Ultrasound System?

Transcranial Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2022-07-08. It is manufactured by Shenzhen Delica Medical Equipment Co., Ltd.. The 510(k) number is K213009.

When was Transcranial Doppler Ultrasound System approved by the FDA?

Transcranial Doppler Ultrasound System received FDA 510(k) clearance on 2022-07-08, under approval number K213009.

What company makes Transcranial Doppler Ultrasound System?

Transcranial Doppler Ultrasound System is manufactured by Shenzhen Delica Medical Equipment Co., Ltd..

What is the FDA product code for Transcranial Doppler Ultrasound System?

The FDA product code for Transcranial Doppler Ultrasound System is IYN.

Related Clinical Trials

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Shenzhen Delica Medical Equipment Co., Ltd.

K173801Transcranial Doppler Ultrasound System K190228Transcranial Doppler Ultrasound System

Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

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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