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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:

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.I. or cardiac surgery.)

5. Clinical and epidemiological Research Studies

6. Norav Holter Systems containing Heart Rate Variability (HRV) software have been of Tronor 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.

Not Found

This FDA 510(k) clearance letter for the Norav Holter Analysis System, Model NH-300, V1.07, does not contain the detailed acceptance criteria or a study description as requested.

The document is a regulatory approval letter, which primarily states that the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not provide specific performance metrics, study designs, or data provenance.

Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, I would need access to the actual 510(k) submission document or a separate clinical study report for the Norav Holter Analysis System.

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