Truvue Wireless Ambulatory ECG Monitoring System

Q: What is the product code of K100155?

The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.

FDA 510(k) K100155 · Biomedical Systems Corp.

Substantially Equivalent

510(k) numberK100155

Submission

Device name: Truvue Wireless Ambulatory ECG Monitoring System
Applicant: Biomedical Systems Corp.
St. Louis, MO, US
Received: January 20, 2010
Decision date: April 20, 2010
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DSI – Detector And Alarm, Arrhythmia
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1025
Specialty: Cardiovascular

Other 510(k)s with product code DSI

510(k)	Device	Applicant	Decision
K243349	BodyGuardian Remote Monitoring System (BGRMS v3.0)DSI · Traditional	Boston Scientific Cardiac Diagnostic…	01/23/2026SE
K250356	MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI · Traditional	Infobionic, Inc.	07/29/2025SE
K240177	Zio AT® device (A100A1001)DSI · Traditional	iRhythm Technologies, Inc.	10/30/2024SE
K230265	MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated	Infobionic, Inc.	10/06/2023SE
K231276	SmartCardia 7L PlatformDSI · Traditional	Smartcardia SA	08/30/2023SE
K193104	Unified Arrhythmia Diagnostic System PocketECG IVDSI · Special	Medicalgorithmics S.A.	04/09/2020SE
K192732	BodyGuardian Remote Monitoring SystemDSI · Traditional	Preventice Technologies, Inc.	03/26/2020SE
K190574	Patient Assistant Model PA97000DSI · Traditional	Medtronic, Inc.	09/24/2019SE
K182532	Liba3 SystemDSI · Traditional	National Cardiac, Inc.	05/15/2019SE
K181658	MobileECG 2 BTDSI · Traditional	Memtec Corporation	03/26/2019SE

More from Memtec Corporation

510(k)	Device	Decision
K024323	Century Series Holter Scanner System, Models C3000, C2000 and C1000MLO · Traditional	06/30/2003SE
K884152	Century Color TraceDSI · Traditional	12/15/1988SE

Questions and answers

When was Truvue Wireless Ambulatory ECG Monitoring System cleared by the FDA?

Truvue Wireless Ambulatory ECG Monitoring System (K100155) received a 510(k) decision of Substantially Equivalent on April 20, 2010, 90 days after the submission was received.

What is the product code of K100155?

The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.