FDA device listing
Advanced PC Based ECG System,ECG-LAN (GREEN),ECGUSB-1,ECGUSB1D-EX,ECGUSB1D-EXR,NHH1200,Norav ECG Management System…
FDA device listing 1571583339 · NORAV MEDICAL
Key facts
| Proprietary names | Advanced PC Based ECG System,ECG-LAN (GREEN),ECGUSB-1,ECGUSB1D-EX,ECGUSB1D-EXR,NHH1200,Norav ECG Management System (NEMS),PC-ECG 1200,PC-ECG 1200HR,PC-ECG 1200M,PC-ECG 1200S,PC-ECG 1200T,PCECG 1200T-03-05-MG,PCECG 1200T (Rev. 03) |
|---|---|
| Owner/operator | NORAV MEDICAL |
| Owner/operator number | 9024500 |
| Premarket submissions | K000404 |
| Product codes | MWI |
| Device names | MWI - Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2300 |
| Review panels | Cardiovascular |
| Registered establishments | Norav Medical Inc., NORAV MEDICAL LTD. |
| Establishment registrations | 9681548, 3008977358 |
| FEI numbers | 3002807745, 3008977358 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database