(38 days)
The Zio® Patch is a prescription only single patient use, continuous recording ECG monitor that can be worn for up to 14 days. It is indicated for use on patients who experience transient symptoms such as syncope, palpitations, shortness of breath, or chest pains.
Not Found
The provided text from the FDA 510(k) summary only covers basic information about the Zio® Patch, its regulation, and approval. It does not contain any information regarding acceptance criteria, study details, or performance data.
Therefore, I cannot provide answers to your specific questions based on the given document.
To answer your questions, I would need a more detailed performance study report or clinical trial summary for the Zio® Patch, which typically includes:
- Specific endpoints (acceptance criteria)
- Statistical methods
- Sample sizes
- Ground truth establishment
- Adjudication
- Results compared to the acceptance criteria.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).