Search Results
Found 1 results
510(k) Data Aggregation
K Number
K102111Device Name
MEDICAL MAGNETIC TAPE RECORDER
Manufacturer
Date Cleared
2010-12-07
(132 days)
Product Code
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
WPR MEDICAL AS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Curvus Sensor - Recorder: Curvus Regular Holter is intended to record single lead (channel) surface ECG data and accelerometer data from ambulatory patients (Holter) for a period of up to 72 hours (3 days). Recorded ECG data are intended to be analyzed by Curvus Analyzer. The Sensor and Recorder are intended for use outside of the hospital. Curvus software suite: Curvus Examiner is intended to program set up and closure of examination, while Curvus Analyzer analyzes the retrieved data from the examination. The system is intended to be used by trained operators under the direct supervision of a trained Health Care Practitioner in a hospital or a clinic environment.
Device Description
The Curvus Regular Holter System is a wireless mobile system for collecting a 1-lead electrocardiogram from a patient and to present the results to medical personnel such as cardiologists with the purpose to assist them to diagnose arrhythmias (heart rhythm irregularities). The Curvus Regular Holter System consists of a set of functional units including software: - Curvus ECG Sensor to be applied to the patient's chest to measure ECG signal . - Curvus ECG Recorder a hand-held device to store monitored data . - Curvus ECG Examiner and Curvus ECG Analyzer software programs to be used by . medical staff for setup and closure of patient examination and for diagnostic evaluation.
Ask a Question
Ask a specific question about this device
Page 1 of 1