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Shenzhen Delica Medical Equipment Co., Ltd.: FDA-registered device maker in SHENZHEN Guangdong, China, 6 510(k) clearances

Name: Shenzhen Delica Medical Equipment Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shenzhen Delica Medical Equipment Co., Ltd. is registered with the FDA (registration 3006441164) in SHENZHEN Guangdong, China. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 8, 2022. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3006441164
Address: 18F, Building B, High-tech park, Guangqiao Road, Tianliao Community, Yutang Street, Guangming District, SHENZHEN Guangdong, China, 518107
Owner or operator: SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD. (9081823)
Roles: Manufacturer
First device listed: November 17, 2006
Registered through: 2027
Brand names listed: Transcranial Doppler Ultrasound System

Devices it lists

Device	Product code	Class	Role	Source
Blood Pressure Cuff	DXQ	2	Manufacturer	accessdata.fda.gov
Diagnostic Ultrasonic Transducer, Robotic	OQQ	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 8, 2022	K213009	Transcranial Doppler Ultrasound System	IYN	Substantially Equivalent	Shenzhen Delica Medical Equipment Co., Ltd.	accessdata.fda.gov
June 13, 2019	K190228	Transcranial Doppler Ultrasound System	IYN	Substantially Equivalent	Shenzhen Delica Medical Equipment Co., Ltd.	accessdata.fda.gov
July 11, 2018	K173801	Transcranial Doppler Ultrasound System	IYN	Substantially Equivalent	Shenzhen Delica Medical Equipment Co., Ltd.	accessdata.fda.gov
February 15, 2013	K122710	TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND	IYN	Substantially Equivalent	Shenzhen Delicate Electronics Co., Ltd.	accessdata.fda.gov
May 13, 2010	K092164	TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA	OQQ	Substantially Equivalent	Shenzhen Delicate Electronics Co., Ltd.	accessdata.fda.gov
May 5, 2006	K060112	NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Nodecrest, LLC	accessdata.fda.gov

Compare with other makers

Updated July 8, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.