# K161062: NR Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Norav Medical GmbH
- Decided: Jun 13, 2016 after 59 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The NR recorder is intended for patients requiring: • Ambulatory (Holter) monitoring • Use within the physician office setting by the medical professional - Resting ECG monitoring (using Bluetooth communication) - 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 or recreational 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

Source page: https://510kreport.com/device/K161062
Methodology: https://510kreport.com/methodology