FDA device listing
989803163181 Mobile CL Disposable Small Adult Cuff,989803163191 Mobile CL Reusable Adult Cuff,989803163201 Mobile CL…
FDA device listing 1237956076 · Philips Medical Systems International BV
Key facts
| Proprietary names | 989803163181 Mobile CL Disposable Small Adult Cuff,989803163191 Mobile CL Reusable Adult Cuff,989803163201 Mobile CL Disposable Adult Cuff,989803163211 Mobile CL Reusable Large Adult Cuff,989803163221 Mobile CL Disposable Large Adult Cuff,989803163251 Mobile CL NBP Cradle Kit,989803168881 Mobile CL Transmitter Cradles,Diverse Specialized Accessories and IntelliVue CL 865220 charging… |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K101600 |
| Product codes | DQA, DRG, DRQ, DRT, DSA, DSI, DSJ, DSK, DXG, DXN, DXQ, MHX and 1 more |
| Device names | DQA - Oximeter, DRG - Transmitters And Receivers, Physiological Signal, Radiofrequency, DRQ - Amplifier And Signal Conditioner, Transducer Signal, DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), DSA - Cable, Transducer And Electrode, Patient, (Including Connector), DSI - Detector And Alarm, Arrhythmia, DSJ - Alarm, Blood-Pressure, DSK - Computer, Blood-Pressure, DXG - Computer, Diagnostic, Pre-Programmed, Single-Function, DXN - System, Measurement, Blood-Pressure, Non-Invasive, DXQ - Blood Pressure Cuff, MHX - Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) and 1 more |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1025, 870.1100, 870.1110, 870.1120, 870.1130, 870.1435, 870.2060, 870.2300, 870.2700, 870.2900, 870.2910 |
| Review panels | Cardiovascular |
| Registered establishments | Philips Electronics Ltd, Philips Medizin Systeme Boeblingen GmbH, Philips North America LLC |
| Establishment registrations | 1218950, 9610816, 3000126629, 3016618143 |
| FEI numbers | 1218950, 3000126629, 3002807167, 3016618143 |
| Establishment operations | Complaint File Establishment, Manufacturer, Foreign Exporter, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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