Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603)

The Automatic Blood Pressure Monitor is a kiosk-type device that measures systolic and diastolic blood pressure and pulse rate in adults using an oscillometric method. It features a fixed tubular arm opening with an integral cuff suitable for arm circumferences of 18–42 cm and displays results on an LED screen.

The subject device uses a resistance-type pressure sensor (versus the predicate's capacitance transducer), supports a wider cuff circumference range (18–42 cm vs. 18–40 cm), employs a ceramic valve for air pressure control (versus electrical control), and measures blood pressure with ±3 mmHg accuracy (versus ±3%). It lacks printer and irregular heartbeat detection functions present in the predicate.

ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01 for clinical accuracy; IEC 80601-2-30 Edition 2.0 2018-03 for device performance; ANSI AAMI ES60601-1 and IEC 60601-1-11 for electrical safety; IEC 60601-1-2 for electromagnetic compatibility; ISO 10993-5, ISO 10993-10, and ISO 10993-23 for biocompatibility.

Both devices employ oscillometric measurement on the upper arm for adults and share the same intended use, design, product code (DXN), and regulatory class (Class II). Although differences exist in sensor type, cuff range, and pressure control method, clinical testing per ISO 81060-2 demonstrates the subject device meets performance requirements. Non-clinical testing confirms electrical safety and EMC compliance. These differences do not raise new questions of safety or effectiveness because the subject device's narrower measurement ranges and different component technologies were validated against state-of-the-art standards and demonstrated comparable clinical performance.