# K111487: NH-301 Ambulatory Ecg Analysis Software

- Pathway: 510(k) (Special)
- Applicant: Norav Medical Corp.
- Decided: Nov 10, 2011 after 163 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
Longest line of descent: 1 generation back to K012712 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012712: Norav Holter System, Model NH-300 V1.07, Norav Medical, Ltd. (2002) Summary page 1.

## Indications for use
The NH-301 Ambulatory ECG Analysis Software is intended for patients requiring ambulatory (Halter) monitoring from i to 168 hours. Such monitoring is most frequently used for the following indications: 1. Evaluation of symptoms suggesting arrfhythmia or myocardial ischemnia. 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 Mil. or cardiac surgery.) 5. Clinical and epidemiological research studies. 6. Norav Hotter 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/K111487
Methodology: https://510kreport.com/methodology