(148 days)
The Colin Press Mate, Model BP S510 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (systolic, diastolic and mean arterial pressures) (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration (RR), body temperature (Temp), invasive blood pressure (IBP) and capnography (EtCO2 and InCO2 ).
Not Found
This is an FDA premarket notification letter for the Colin Press Mate, Model BP S510. This type of document typically does not contain the detailed study information you are requesting. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which means specific performance data and acceptance criteria are usually not presented in this summary letter itself.
To answer your questions, you would need access to the full 510(k) submission document (K063690), which would contain the detailed pre-clinical and clinical study reports. The FDA letter only serves as an approval based on the information provided in that submission.
Therefore, I cannot provide the requested information from the provided text.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.