easuring part:Upper arm part
Measurement methods
ulse Scanning/Oscillography
working environment:Operating temperature: 10℃~40℃ Operating humidity: 40%~85%
Material quality
C+ABS
Measuring range:Blood pressure 0~280mmHg (0~37.3kpa), pulse rate 40~195 beats/min
measurement accuracy:Blood pressure value ±0.4kpa (±3mmHg), ±5% of pulse rate reading
Storage environment
torage temperature: -20℃~50℃ Storage humidity: 15%~90%
Closing method:60S after manual closing or no operation
Product Size:116*91*63mm
FDA Approved medical devices
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
Which
Digital Blood Pressure Monitor is FDA approved?
Digital Blood Pressure Monitor sold in the United States should FDA approved. This approval, officially recognized under a code called 510k certification.
How do I know if a Digital Blood Pressure Monitor is FDA approved?
The FDA provides several ways for you to check if the FDA approved or cleared a medical device or, as described below if the FDA authorized the device to be used during a public health emergency. Check for Approved and Cleared Products in the Devices@FDA Database: Devices@FDA is a catalog of approved and cleared medical device information from the FDA. Go to the Devices@FDA Database.