EMMa Electronic Monitoring Management

FDA 510(k) K153477 · Vitasystems GmbH

Substantially Equivalent

510(k) numberK153477

Submission

Device name
EMMa Electronic Monitoring Management
Applicant
Vitasystems GmbH
Mannheim, DE
Received
December 2, 2015
Decision date
May 25, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 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)DeviceApplicantDecision
K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)DSI · Traditional Boston Scientific Cardiac Diagnostic…01/23/2026SE
K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI · Traditional Infobionic, Inc.07/29/2025SE
K240177Zio AT® device (A100A1001)DSI · Traditional iRhythm Technologies, Inc.10/30/2024SE
K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated Infobionic, Inc.10/06/2023SE
K231276SmartCardia 7L PlatformDSI · Traditional Smartcardia SA08/30/2023SE
K193104Unified Arrhythmia Diagnostic System PocketECG IVDSI · Special Medicalgorithmics S.A.04/09/2020SE
K192732BodyGuardian Remote Monitoring SystemDSI · Traditional Preventice Technologies, Inc.03/26/2020SE
K190574Patient Assistant Model PA97000DSI · Traditional Medtronic, Inc.09/24/2019SE
K182532Liba3 SystemDSI · Traditional National Cardiac, Inc.05/15/2019SE
K181658MobileECG 2 BTDSI · Traditional Memtec Corporation03/26/2019SE

More from Memtec Corporation

510(k)DeviceDecision
K151013Vitaphone Tele ECG Loop RecorderDXH · Traditional 04/30/2015SE
K100383Vitaphone. Model 100 BTDXH · Traditional 04/20/2010SE

Questions and answers

When was EMMa Electronic Monitoring Management cleared by the FDA?

EMMa Electronic Monitoring Management (K153477) received a 510(k) decision of Substantially Equivalent on May 25, 2016, 175 days after the submission was received.

What is the product code of K153477?

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