PC-180 / Prince 180 Easy ECG Monitor
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K073152 FDA 510(k)
- FDA Product Code
- DSH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2800 FDA 510(k)
- Regulation Number
- 870.2800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PC-180 / Prince 180 Easy ECG Monitor is a medical device classified as a Recorder, Magnetic Tape, designed for capturing and recording electrocardiogram (ECG) signals. It is intended for continuous monitoring of cardiac electrical activity, providing real-time data for diagnostic and clinical assessment of heart function.
This device is supplied as a reusable medical instrument, intended for use in clinical settings such as hospitals and cardiac care units. It adheres to regulatory standards including FDA 510(k) clearance and MDR compliance, with a classification under device code 870.2800. The monitor is intended for professional use by trained healthcare personnel and requires proper maintenance and storage to ensure accurate and reliable ECG recordings.
Frequently asked questions
Is the PC-180 / Prince 180 Easy ECG Monitor designed for single-use or reusable in clinical settings?
The PC-180 / Prince 180 Easy ECG Monitor is explicitly described as a reusable medical instrument. It is intended for use in clinical settings like hospitals and cardiac care units, requiring proper maintenance to ensure accurate and reliable ECG recordings over multiple uses.
What types of regulatory approvals does the PC-180 / Prince 180 Easy ECG Monitor hold?
The device holds FDA 510(k) clearance and MDR compliance, confirming its adherence to regulatory standards in the United States and European markets. It was classified under device code 870.2800 and received a substantially equivalent determination by the FDA’s Cardiovascular (CV) advisory committee.
How is the PC-180 / Prince 180 Easy ECG Monitor intended to be used in a clinical environment?
This device is designed for continuous monitoring of cardiac electrical activity via electrocardiogram (ECG) recordings. It captures real-time data for diagnostic and clinical assessment of heart function, intended exclusively for use by trained healthcare personnel in settings like hospitals or cardiac care units.
What storage or maintenance considerations should be taken for the PC-180 / Prince 180 Easy ECG Monitor?
While the device data does not specify exact storage conditions, as a reusable medical instrument, it requires proper maintenance to ensure accuracy and reliability. This likely includes regular cleaning, calibration, and adherence to manufacturer guidelines to prevent degradation of performance over time.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K073152 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Creative Industry Co., Ltd.
Sources (2)
- FDA 510(k) K073152 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026