(84 days)
The Zio TM 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.
The Zio TM patch is a prescription only single patient use, continuous recording ECG monitor that can be worn for up to 14 days.
This document is a 510(k) clearance letter for the Zio™ patch Model Z100 from the U.S. FDA, dated May 8, 2009. It primarily grants market clearance and defines the indications for use. It does not contain detailed information about acceptance criteria or a study proving the device meets said criteria.
Therefore, I cannot provide the requested information based on the provided text. The document is for regulatory clearance and states that the device is substantially equivalent to legally marketed predicate devices, but it does not include performance data or study details.
§ 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).