Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014982325

FEI Number

3014982325

Entity Name

QT Medical, INC. Taiwan Branch

City/State/Country

New Taipei City, TW

Establishment Address

14F.-8, No. 2, Jian 8th Rd., Zhonghe Dist., New Taipei City 235, TW

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

QT MEDICAL, INC (Owner Number: 10058094)

Owner / Operator Contact Address

1370 Valley Vista Drive, Suite 266, Diamond Bar, CA 91765, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220795

PMA Number

N/A

All Registered Proprietary Names

PCA 500 QT ECG 12-Lead Electrocardiograph ECG Recorder (PCA 300)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2022-12-16

Official Correspondent

Yu-Ting Chen

US Agent Details

Ying-lung Cheng Business: QT MEDICAL, INC Email: yl.cheng@qtmedical.com Phone: (424) 5583500

Related Public Records

Same Entity

QT MEDICAL, INC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013684844	QT MEDICAL, INC	Diamond Bar, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K820986	Dart Medical Equipment	EKG MONITORS, VARIOUS MODELS	1982-04-29
K910450	Medtech Industries, Inc.	CARD GUARD-3000 ECG TELEPHONE ADAPTER	1991-05-07
K761318	Cambridge Instruments, Inc.	3038 OPTION B-COMPUT. TRANS. TERMINAL	1977-01-06
K972649	Reynolds Medical , Ltd.	CARDIOCALL CARDIAC EVENT RECORDER	1997-12-04
K033410	Remote Diagnostic Technologies , Ltd.	TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002	2004-03-05

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3015976873	QOMPIUM NV	Hasselt Limburg, BE
3010742884	Otsuka America Pharmaceutical, Inc	Hayward, CA, US
3042928308	TAIWAN SCIENTIFIC CORPORATION	New Taipei, TW
3017884848	KITRON TECHNOLOGIES INC.	Windber, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014982325. Last updated year: 2026. Please use registration number 3014982325 when referencing this establishment in official correspondence.