FDA device listing
989803157481, DigiTrak XT Patient Cable, Short,989803157491, DigiTrak XT Patient Cable, Medium,989803157501, DigiTrak XT…
FDA device listing 1482820710 · Philips Medical Systems International BV
Key facts
| Proprietary names | 989803157481, DigiTrak XT Patient Cable, Short,989803157491, DigiTrak XT Patient Cable, Medium,989803157501, DigiTrak XT Patient Cable, Long,DigiTrak XT Holter Recorder w/Leadwires,DL950 Holter System |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K071733 |
| Product codes | MWJ |
| Device names | MWJ - Electrocardiograph, Ambulatory (Without Analysis) |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2800 |
| Review panels | Cardiovascular |
| Registered establishments | Philips (China) Investment Co., Ltd. Philips Healthcare - Shanghai CDC, Philips Medizin Systeme Boeblingen GmbH, Philips North America LLC |
| Establishment registrations | 1218950, 9610816, 3012027770, 3012528160, 3016618143, 3016701404 |
| FEI numbers | 1218950, 3002807167, 3012027770, 3012528160, 3016618143, 3016701404 |
| Establishment operations | Complaint File Establishment, Specification Developer, Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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