FDA device listing
989803172031 SPU ECG Lead Set, 5 Lead, AAMI, Grabber,989803172051 ECG 5 lead Graber, AAMI + SpO2, SPU, Tele,989803172131…
FDA device listing 1967716699 · Philips Medical Systems International BV
Key facts
| Proprietary names | 989803172031 SPU ECG Lead Set, 5 Lead, AAMI, Grabber,989803172051 ECG 5 lead Graber, AAMI + SpO2, SPU, Tele,989803172131 SPU ECG Lead Set, 5 Lead, AAMI, Grabber,989803172151 ECG 5 lead Grabber, IEC + SpO2,SPU,Tele,989803172221 ECG 5L Grabber, AAMI, SpO2, Tele,Intellivue MX40 Patient Monitor |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K113125 |
| Product codes | DQA, DRG, DRW, DSA, DSI, MHX, MLD, MSX |
| Device names | DQA - Oximeter, DRG - Transmitters And Receivers, Physiological Signal, Radiofrequency, DRW - Adaptor, Lead Switching, Electrocardiograph, DSA - Cable, Transducer And Electrode, Patient, (Including Connector), DSI - Detector And Alarm, Arrhythmia, MHX - Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), MLD - Monitor, St Segment With Alarm, MSX - System, Network And Communication, Physiological Monitors |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1025, 870.2300, 870.2350, 870.2700, 870.2900, 870.2910 |
| Review panels | Cardiovascular |
| Registered establishments | Philips Electronics Ltd, Philips North America LLC |
| Establishment registrations | 1218950, 3000126629, 3012528160, 3016618143 |
| FEI numbers | 1218950, 3000126629, 3012528160, 3016618143 |
| Establishment operations | Complaint File Establishment, Specification Developer, Contract Manufacturer, Foreign Exporter |
| 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