Search Results
Found 1 results
510(k) Data Aggregation
K Number
K112921Device Name
MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
Manufacturer
MEDICAL.GORITHMICS S.A.
Date Cleared
2012-05-16
(226 days)
Product Code
DSI
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL.GORITHMICS S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use for the PocketECG v2 monitor are as follows:
1. Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease
2. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness: b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath)
3. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
4. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring
6. Patients with diagnosed sleep disordered breathing including sleep annea (obstructive, central) to evaluate possible nocturnal arrhythmias
7. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter.
8. Data from the device may be used by another device to analyze, measure or report OT interval. The device is not intended to sound any alarms for OT interval changes.
Device Description
PocketECG v2 - Medicalgorithmics Unified Arrhythmia Diagnostic System is an ambulatory ECG monitor which analyzes electrographic signal, classifies all detected heart beats and recognizes rhythm abnormalities. All detection results, including annotations for every detected heart beat and the entire ECG signal are transmitted via cellular telephony network to a remote server accessible by a Monitoring Center for reviewing by trained medical staff.
The patient worn transmitter streams via Bluetooth link the ECG signal to a Windows Mobile or Android OS operated PDA (Personal Digital Assistant) device with mobile phone capabilities. The PDA runs Medicalgorithmics proprietary software which produces QRS annotations and manages the data transmission. The PDA device transmits and stores the entire ECG on its storage card.
Ask a Question
Page 1 of 1