(29 days)
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel .
The intended for use of this over-the-counter device is for age 16 and above.
Full Automatic (NIBP) Blood Pressure Monitor
Here's an analysis of the provided text regarding acceptance criteria and device performance:
No specific acceptance criteria or study details are provided in the given document.
The document is a 510(k) clearance letter from the FDA for the device "HL168R" (a Full Automatic (NIBP) Blood Pressure Monitor). This letter grants clearance for the device based on a finding of "substantial equivalence" to a legally marketed predicate device.
The FDA's decision of substantial equivalence often relies on performance data submitted by the manufacturer, but this specific letter does not contain those data or the acceptance criteria used. It refers to the manufacturer's 510(k) premarket notification as the source of the information that led to the determination.
Therefore, I cannot fulfill the request for a table of acceptance criteria, study details, and specific performance metrics based solely on the provided text.
To answer your request, I would need access to the actual 510(k) submission document for K031695, not just the FDA clearance letter. That document would contain the detailed studies conducted, their methodologies, and the acceptance criteria applied.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).