QT ECG (QTERD100)

Q: When was QT ECG (QTERD100) cleared by the FDA?

QT ECG (QTERD100) (K233521) received a 510(k) decision of Substantially Equivalent on December 6, 2023, 35 days after the submission was received.

Q: What is the product code of K233521?

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) K233521 · QT Medical, Inc.

Substantially Equivalent

510(k) numberK233521

Submission

Device name: QT ECG (QTERD100)
Applicant: QT Medical, Inc.
Diamond Bar, CA, US
Received: November 1, 2023
Decision date: December 6, 2023
Decision: Substantially Equivalent (SESE)
Type: Special 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

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K222842	V-Patch Cardiac MonitorDXH · Traditional	Shandong Corecare Technology Limited	10/20/2022SE
K220795	QT ECGDXH · Traditional	QT Medical, Inc.	09/26/2022SE
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
K220795	QT ECGDXH · Traditional	09/26/2022SE
K200722	PCA-C1 series Patient CableDSA · Traditional	06/03/2021SE
K180157	QT ECGDXH · Traditional	05/04/2018SE

Questions and answers

When was QT ECG (QTERD100) cleared by the FDA?

QT ECG (QTERD100) (K233521) received a 510(k) decision of Substantially Equivalent on December 6, 2023, 35 days after the submission was received.

What is the product code of K233521?

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