Data / Medical devices / Israel / Norav Medical Ltd.
Norav Medical Ltd.: FDA-registered device maker in YOKNEAM Northern, Israel, 1 510(k) clearance
Norav Medical Ltd. is registered with the FDA (registration 9681548) in YOKNEAM Northern, Israel. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 22, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681548
- FEI number
- 3002807745
- Address
- 4 Hamada ST., YOKNEAM Northern, Israel, 20692
- Owner or operator
- NORAV MEDICAL (9024500)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 24, 2006
- Registered through
- 2026
- Brand names listed
- Advanced PC Based ECG System, Advanced wireless PC based ECG, Blue-ECG, ECG-LAN (GREEN), ECGBT2, ECGUSB-1, ECGUSB1D-EX, ECGUSB1D-EXR and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | 2 | Contract manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 22, 2000 | K000404 | PC ECG 1200 | MWI | Substantially Equivalent | Norav Medical , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Electrocardiograph, Ambulatory, With Analysis Algorithm
- All makers of Electrocardiograph, Ambulatory (Without Analysis)
Updated November 22, 2000. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.