Data / Medical devices / United States / Norav Medical Inc.
Norav Medical Inc.: FDA-registered device maker in Delray Beach, FL, United States, 6 510(k) clearances
Norav Medical Inc. is registered with the FDA (registration 3008977358) in Delray Beach, FL, United States. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 13, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008977358
- Address
- 1300 Wallace Dr, Delray Beach, FL, United States, 33444
- Owner or operator
- NORAV MEDICAL (9024500)
- Roles
- Complaint file establishment, Repackager or relabeler
- 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 | Complaint file establishment | accessdata.fda.gov |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 13, 2016 | K161062 | NR Recorder | MWJ | Substantially Equivalent | Norav Medical GmbH | accessdata.fda.gov |
| November 10, 2011 | K111487 | NH-301 AMBULATORY ECG ANALYSIS SOFTWARE | MLO | Substantially Equivalent | Norav Medical Corp. | accessdata.fda.gov |
| November 10, 2011 | K110463 | PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) | MWI | Substantially Equivalent | Norav Medical , Ltd. | accessdata.fda.gov |
| April 25, 2008 | K080141 | PC ECG 1200W SYSTEM | MWI | Substantially Equivalent | Norav Medical , Ltd. | accessdata.fda.gov |
| May 8, 2002 | K012712 | NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 | MLO | Substantially Equivalent | Norav Medical , Ltd. | accessdata.fda.gov |
| 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 (Without Analysis)
- All makers of Electrocardiograph, Ambulatory, With Analysis Algorithm
Updated June 13, 2016. 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.