Norav Holter System, Model NH-300 V1.07
by Norav Medical, Ltd. EUDAMED510(k)
Active
510(k) K012712
Overview
The Norav Holter System, Model NH-300 V1.07 is an ambulatory electrocardiograph designed for continuous, long-term recording of the heart’s electrical activity. It incorporates an analysis algorithm to monitor and interpret cardiac rhythms over extended periods, aiding in the diagnosis of arrhythmias and other cardiovascular conditions.
This device is supplied as a reusable system and is intended for use in clinical settings, including hospitals and outpatient facilities. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDR authorization. The system operates without MRI restrictions and requires proper storage and maintenance as specified in the manufacturer’s instructions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK012712 | Date8 May 2002 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- MLO
- FDA applicant
- Norav Medical , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2800
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Norav Medical, Ltd.
Questions
What clinical conditions is the Norav Holter System, Model NH-300 V1.07, primarily used to diagnose or monitor?
The Norav Holter System, Model NH-300 V1.07, is designed for continuous, long-term recording of the heart’s electrical activity to aid in diagnosing arrhythmias and other cardiovascular conditions. Its integrated analysis algorithm helps monitor and interpret cardiac rhythms over extended periods, making it useful for identifying irregular heartbeats or other abnormalities during daily activities.
Is the Norav Holter System reusable, and if so, what maintenance requirements should be followed?
Yes, the Norav Holter System, Model NH-300 V1.07, is supplied as a reusable system intended for clinical settings like hospitals and outpatient facilities. Proper storage and maintenance must be followed as outlined in the manufacturer’s instructions to ensure accurate performance and longevity of the device.
Can this Holter monitor be used in patients who require MRI scans, or does it have any MRI restrictions?
The Norav Holter System, Model NH-300 V1.07, explicitly states it operates without MRI restrictions, meaning it can be used in patients who need MRI scans without interference or safety concerns.
What regulatory pathways has the Norav Holter System, Model NH-300 V1.07, undergone, and which governing bodies have authorized its use?
The Norav Holter System, Model NH-300 V1.07, has received FDA 510(k) clearance and MDR authorization. It is classified as a Class II medical device under FDA regulations, with its submission reviewed by the Cardiovascular (CV) Advisory Committee.
What types of clinical environments is this Holter monitor intended for, and how is it typically supplied?
The Norav Holter System, Model NH-300 V1.07, is intended for use in clinical settings such as hospitals and outpatient facilities. It is supplied as a reusable system, meaning it is designed for repeated use within these controlled environments, rather than single-patient disposable use.