Data / Medical devices / United States / Neo Medical Usa, Inc.

Neo Medical Usa, Inc.: FDA-registered device maker in San Jose, CA, United States, 1 510(k) clearance

Name: Neo Medical Usa, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Neo Medical Usa, Inc. is registered with the FDA (registration 3031823165) in San Jose, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 24, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3031823165
Address: 832 Jury Ct Ste 10, San Jose, CA, United States, 95112
Owner or operator: Neo Medical Inc. (10091114)
Roles: Repackager or relabeler, Specification developer
First device listed: January 29, 2026
Registered through: 2026
Brand names listed: NEO MEDICAL

Devices it lists

Device	Product code	Class	Role	Source
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Repackager or relabeler, Specification developer	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
October 24, 2023	K231509	Aco Apache Ultrasound System	IYN	Substantially Equivalent	Aco Healthcare Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated October 24, 2023. 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.