Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013684844

FEI Number

3013684844

Entity Name

QT MEDICAL, INC

City/State/Country

Diamond Bar, CA, US

Establishment Address

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

Establishment Type(s)

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

K200722

PMA Number

N/A

All Registered Proprietary Names

PCA 500 PCA 500+ PCA 500 QT ECG 12-Lead Electrocardiograph ECG Recorder (PCA 300) QT ECG 12-Lead Electrocardiograph PCA-C100BS AHA Patient Cable PCA-C100 AHA Patient Cable PCA-C100BL AHA Patient Cable PCA-C101BS IEC Patient Cable PCA-C101BL IEC Patient Cable PCA-C101 IEC Patient Cable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2023-12-08
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2023-12-08
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2022-12-16
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2018-07-15
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2021-06-21

Official Correspondent

Yu-Ting Chen

US Agent Details

No US Agent registered (Local establishment).

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
3014982325	QT Medical, INC. Taiwan Branch	New Taipei City, TW

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07
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

Similar Registrations

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3013522941	JOHNSON MEDTECH LLC	Vandalia, OH, US
3013873578	SHANGHAI YUECHEN MEDICAL SUPPLY CO..LTD.	Shanghai, CN
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3017425211	LOHMANN PRECISION DIE CUTTING, LLC	Orange, VA, US
3008773647	CARDIONET, LLC	Phoenix, AZ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013684844. Last updated year: 2026. Please use registration number 3013684844 when referencing this establishment in official correspondence.