FDA device listing
Advanced Apps ECG Cable - 989803176381,Expression IP5 Information Portal,Expression IP5 Software Upgrade…
FDA device listing 1206754884 · Philips Medical Systems International BV
Key facts
| Proprietary names | Advanced Apps ECG Cable - 989803176381,Expression IP5 Information Portal,Expression IP5 Software Upgrade - 989803197491,Expression MR200 MRI Patient Monitoring System,Expression MR200 New MRI Monitor Accessories - 866177,Expression MR Wireless ECG Patient Module - 989803183661,NiBP Cuff, Single Lumen, Adult - 989803182641,NiBP Cuff, Single Lumen, Adult, Disp - 989803182541,NiBP Cuff, Single Lumen… |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K131382 |
| 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 | INVIVO CORPORATION, Philips Electronics Ltd, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Philips Medizin Systeme Boeblingen GmbH, Philips North America LLC |
| Establishment registrations | 1051786, 9610816, 3000126629, 3003768277, 3012528160, 3016618143, 3016701404 |
| FEI numbers | 1051786, 3000126629, 3002807167, 3002807880, 3012528160, 3016618143, 3016701404 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Foreign Exporter, Repackager/Relabeler, Specification Developer |
| 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