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510(k) Data Aggregation
K Number
K161062Device Name
NR Recorder
Manufacturer
Norav Medical GmbH
Date Cleared
2016-06-13
(59 days)
Product Code
MWJ
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
Norav Medical GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NR recorder is intended for patients requiring: · Ambulatory (Holter) monitoring · Use within the physician office setting by the medical professional ECG monitoring (using Bluetooth communication) - Resting - Telemetry ECG monitoring (using Bluetooth communication) Such monitoring is most frequently used for the indications below: · Evaluation of symptoms suggesting arrhythmia or myocardial ischemia · Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients · Evaluation of patients for ST segment changes · Evaluation of a patient's response after resuming occupational activities (for example, after myocardial infarction or cardiac surgery) · Clinical and epidemiological research studies · Evaluation of patients with pacemakers · Reporting of time and frequency domain heart rate variability · Reporting of QT interval
Device Description
NR Recorder
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