QT ECG

Q: When was QT ECG cleared by the FDA?

QT ECG (K220795) received a 510(k) decision of Substantially Equivalent on September 26, 2022, 192 days after the submission was received.

Q: What is the product code of K220795?

The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.

FDA 510(k) K220795 · QT Medical, Inc.

Substantially Equivalent

510(k) numberK220795

Submission

Device name: QT ECG
Applicant: QT Medical, Inc.
Diamond Bar, CA, US
Received: March 18, 2022
Decision date: September 26, 2022
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DXH – Transmitters And Receivers, Electrocardiograph, Telephone
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2920
Specialty: Cardiovascular

Other 510(k)s with product code DXH

510(k)	Device	Applicant	Decision
K250233	PreemptiveAI Clinical SDKDXH · Traditional	Measure Labs, Inc. (Dba Preemptiveai, Inc.)	02/13/2026SE
K250258	HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemDXH · Traditional	Heartbeam, Inc.	12/08/2025SE
K243438	MEMO Patch M (MPT-E08R-UNC01)DXH · Traditional	Huinno Co., Ltd.	12/05/2025SE
K243981	Hexoskin Medical System (7100-00016)DXH · Traditional	Carre Technologies, Inc.	11/18/2025SE
K243003	VitalSigns 1-Lead Holter (VSH101)DXH · Traditional	VitalSigns Technology Co., Ltd.	06/17/2025SE
K233521	QT ECG (QTERD100)DXH · Special	QT Medical, Inc.	12/06/2023SE
K222842	V-Patch Cardiac MonitorDXH · Traditional	Shandong Corecare Technology Limited	10/20/2022SE
K213357	Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorDXH · Traditional	Verily Life Sciences, LLC	07/19/2022SE
K220350	KardiaMobile 6LDXH · Traditional	AliveCor, Inc.	05/25/2022SE
K211668	KardiaMobile CardDXH · Special	AliveCor, Inc.	11/30/2021SE

More from AliveCor, Inc.

510(k)	Device	Decision
K233521	QT ECG (QTERD100)DXH · Special	12/06/2023SE
K200722	PCA-C1 series Patient CableDSA · Traditional	06/03/2021SE
K180157	QT ECGDXH · Traditional	05/04/2018SE

Questions and answers

When was QT ECG cleared by the FDA?

QT ECG (K220795) received a 510(k) decision of Substantially Equivalent on September 26, 2022, 192 days after the submission was received.

What is the product code of K220795?

The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.