(51 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 . . . : ー The intended for use of this over-the-counter device is for adult patients whose arm circumference between 24-32cm (approx. 8.7" to 12.6" ) .
H&L Full Automatic (NIBP) Blood Pressure Monitor, Trade Name : HL888HA. 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.
This document is a 510(k) clearance letter from the FDA for a non-invasive blood pressure measurement system (HL888HA). It does not contain a study report or detailed information about the acceptance criteria and performance of the device beyond its classification and indication for use. Therefore, I cannot provide the requested information about the study that proves the device meets specific acceptance criteria based on this document.
The document indicates:
- Device Name: H&L Full Automatic (NIBP) Blood Pressure Monitor (Trade Name: HL888HA)
- Regulation Number: 21 CFR 870.1130 (Non-invasive Blood Pressure Measurement System)
- Regulatory Class: Class II
- Indications For Use: Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. Intended for adult patients whose arm circumference is between 24-32 cm.
To answer your request, a separate study report or a more detailed submission document (which is not provided) would be needed.
§ 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).