Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)

The Clinical Automatic Blood Pressure Monitor (DBP-20, DBP-20i) is a digital device that measures systolic and diastolic blood pressure and pulse rate in adults at hospitals and medical establishments. The DBP-20i includes voice broadcast of results, while the DBP-20 does not. Results are displayed on an LCD screen for physician reference in diagnosis.

The subject device uses oscillometric measurement method with automatic internal pump inflation and rapid deflation, measuring pressure ranges of 0-290 mmHg (vs. 0-289 mmHg predicate) and pulse rates of 40-200 bpm. Both devices are Class I Type B electrical protection, operate at 5°C-40°C with LCD displays, use mains power, and accommodate arm circumferences of 17-42 cm with ±3 mmHg pressure accuracy.

Electrical safety testing per IEC 60601-1 and IEC 80601-2-30; electromagnetic compatibility per IEC 60601-1-2; and clinical validation per ISO 81060-2:2018 for non-invasive sphygmomanometers.

The subject device is substantially equivalent because it shares identical intended use, patient population (adult, non-pregnant), measurement site (upper arm), method (oscillometric), and functional specifications with the predicate device DBP-01P/DBP-01HP. The minor differences in measurement range and weight do not raise new safety or effectiveness concerns, and clinical testing demonstrates accuracy within acceptable ISO 81060-2 standards.