FDA device listing
989803129231, Alligator Clips, AMMI,989803166031, Clear Tab/Snap Adapter,989803175891, 12-Lead Patient Cable (IEC)…
FDA device listing 1326818218 · Philips Medical Systems International BV
Key facts
| Proprietary names | 989803129231, Alligator Clips, AMMI,989803166031, Clear Tab/Snap Adapter,989803175891, 12-Lead Patient Cable (IEC), Standard Length,989803175901, 12-Lead Patient Cable (AAMI), Standard Length,989803175911, 12-Lead Patient Cable (IEC), Long,989803175921, 12-Lead Patient Cable (AAMI), Long,PageWriter TC20,PageWriter TC20, TC30, TC50, TC70 w/PIM, Lead Sets, Adapters, Electrodes |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K113144 |
| Product codes | DPS |
| Device names | DPS - Electrocardiograph |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2340 |
| Review panels | Cardiovascular |
| Registered establishments | Philips (China) Investment Co., Ltd. Philips Healthcare - Shanghai CDC, Philips Electronics Ltd, Philips Medizin Systeme Boeblingen GmbH |
| Establishment registrations | 9610816, 3000126629, 3012027770 |
| FEI numbers | 3000126629, 3002807167, 3012027770 |
| 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