Home / 510(k) Clearances / K133753

510(k) K133753

MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR by Infobionic, Inc. — Product Code QYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2014
Date Received
December 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Outpatient Cardiac Telemetry
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Devices are intended to continuously record and analyze electrocardiograms for automatic detection and recording of cardiac electrical activity in an outpatient setting. Detected, notifiable events are transmitted to the prescribing clinician during the monitoring period by a 24/7 attended analysis center after review by a qualified individual. Devices may allow remote access and display of electrocardiograms acquired. Not for use for detection or notification of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. Not intended for patients at elevated risk of serious cardiovascular events that would require prompt intervention. It is not intended for monitoring patients during cardiac rehabilitation outside of healthcare facilities. Devices are intended for prescription use only.

Other clearances by Infobionic, Inc.

  • K250356 — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) (July 29, 2025)
  • K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System (October 6, 2023)
  • K160064 — MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System (March 11, 2016)
  • K152491 — MoMe Software Platform (December 17, 2015)

Other clearances for product code QYX

  • K241179 — Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) (July 11, 2025)
  • K240653 — SmartCardia 7L Platform (MCT) (October 31, 2024)
  • K240029 — Zio AT® device (A100A1001) (October 21, 2024)
  • K233584 — RhythmStar System (July 8, 2024)
  • K162956 — NOWCARDIO SYSTEM (September 22, 2017)
  • K170565 — LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L (August 1, 2017)
  • K163512 — Zio AT ECG Monitoring System (June 2, 2017)
  • K160064 — MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System (March 11, 2016)
  • K133701 — NUVANT MCT SYSTEM (February 6, 2014)
  • K113372 — NUVANT, MOBILC CARDIAC TELEMETRY (March 7, 2012)