FDA device listing
Holter 1810/ 2010 SW
FDA device listing 1111717317 · Philips Medical Systems International BV
Key facts
| Proprietary names | Holter 1810/ 2010 SW |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K010949 |
| Product codes | MLO |
| Device names | MLO - Electrocardiograph, Ambulatory, With Analysis Algorithm |
| 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 Electronics Ltd, Philips North America LLC |
| Establishment registrations | 1218950, 3000126629, 3012027770, 3012528160, 3016618143, 3016701404 |
| FEI numbers | 1218950, 3000126629, 3012027770, 3012528160, 3016618143, 3016701404 |
| Establishment operations | Complaint File Establishment, Contract 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