PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardi…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191738 FDA 510(k)
- FDA Product Code
- DPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2340 FDA 510(k)
- Regulation Number
- 870.2340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PageWriter TC20, TC30, TC50, and TC70 Cardiographs are electrocardiograph (ECG) devices designed to record and display the electrical activity of the heart. These systems provide real-time tracing of cardiac rhythms, enabling clinicians to diagnose arrhythmias, ischemia, and other cardiac conditions through printed or digital output.
These devices are intended for use in clinical settings such as hospitals, emergency rooms, and cardiac care units. Supplied as reusable medical equipment, they require proper maintenance and calibration to ensure accurate readings. Authorized under FDA 510K and MDD compliance, the PageWriter series adheres to regulatory standards for cardiovascular diagnostic devices, with no specific MRI safety restrictions noted.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K191738 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems
Sources (2)
- FDA 510(k) K191738 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026