The following data is part of a premarket notification filed by Health & Life Co., Ltd with the FDA for Full Automatic (nibp) Blood Pressure Monitor, Model Hl858dm.
|Device Name:||Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM|
|Classification||System, Measurement, Blood-pressure, Non-invasive|
|Applicant||Health & Life Co., Ltd 9F, No. 186, Jian Yi Road, Zhonghe District New Taipei City, TW 23553|
Health & Life Co., Ltd 9F, No. 186, Jian Yi Road, Zhonghe District New Taipei City, TW 23553
|CFR Regulation Number||870.1130 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|