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510(k) Data Aggregation
K Number
K111487Device Name
NH-301 AMBULATORY ECG ANALYSIS SOFTWARE
Manufacturer
Date Cleared
2011-11-10
(163 days)
Product Code
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
NORAV MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NH-301 Ambulatory ECG Analysis Software is intended for patients requiring ambulatory (Holter) monitoring from 1 to 168 hours. Such monitoring is most frequently used for the following indications:
1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
3. Evaluation of patients for ST segment changes.
4. Evaluation of patient's response after resuming occupational or recreational activities, (e.g., after M.I. or cardiac surgery.)
5. Clinical and epidemiological research studies.
6. Norav Holter Systems containing Heart Rate Variability (HRV) software have been tested to measure Heart Rate Variability within 4 ms tolerance. The clinical significance of Heart Rate Variability measures should be determined by a physician.
7. Evaluation of patients with pacemakers
Device Description
The NH-301 Ambulatory ECG Analysis Software is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value.
The Software uploads long term ECG data from compatible ambulatory ECG recorders, analyzes via an algorithm and then displays it on the color monitor, in a manner that allows the analyses to be edited and reported. Several parameters are adjustable in the set-up of the analysis system.
The Software has an open architecture designed to operate on various IBM PC or compatible. It uses r his convalion printer. Instead of designing a computer inside a medical instrument, the instrument is delivered as a software and interface assembly to be used with an off the shelf computer system. This technique enhances the system cost effectiveness and reliability.
Acquired data is stored, and subsequently transferred to the PC for display. Up to 12 channels of real time ECG display are possible. The available commands, calculation of results and status messages are also displayed. All commands are initiated via keyboard.
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