Mome ECG Continuous Detection and Arrhythmia Detector
FDA 510(k) K133753 · Infobionic, Inc.
510(k) numberK133753
Submission
- Device name
- Mome ECG Continuous Detection and Arrhythmia Detector
- Applicant
- Infobionic, Inc.
Lowell, MA, US - Received
- December 9, 2013
- Decision date
- September 19, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QYX – Outpatient Cardiac Telemetry
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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…
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| K133701 | Nuvant MCT SystemQYX · Special | Corventis, Inc. | 02/06/2014SE |
More from Corventis, Inc.
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|---|---|---|
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI · Traditional | 07/29/2025SE |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated | 10/06/2023SE |
| K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemQYX · Abbreviated | 03/11/2016SE |
| K152491 | MoMe Software PlatformDSI · Traditional | 12/17/2015SE |
Questions and answers
When was Mome ECG Continuous Detection and Arrhythmia Detector cleared by the FDA?
Mome ECG Continuous Detection and Arrhythmia Detector (K133753) received a 510(k) decision of Substantially Equivalent on September 19, 2014, 284 days after the submission was received.
What is the product code of K133753?
The FDA product code is QYX – Outpatient Cardiac Telemetry, a Class II (moderate risk) device regulated under 21 CFR 870.1025.