# K012712: Norav Holter System, Model NH-300 V1.07

- Pathway: 510(k) (Traditional)
- Applicant: Norav Medical, Ltd.
- Decided: May 8, 2002 after 267 days
- Product code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K111487: NH-301 Ambulatory Ecg Analysis Software (2011), 0 descendants of its own

## Indications for use
The Norav Holter Analysis System is intended for patients requiring ambulatory {Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below: A . 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 a patient’s response after resuming occupational or recreational activities (e.g. after M.. 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.

Source page: https://510kreport.com/device/K012712
Methodology: https://510kreport.com/methodology