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510(k) Data Aggregation
K Number
K131026Device Name
BOSCH BLOOD PRESSURE METER (BP5000 BT)
Manufacturer
Date Cleared
2013-11-14
(216 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ROBERT BOSCH HEALTHCARE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Bosch Blood Pressure Monitor (BP5000 BT) is intended for use by adults to measure systolic and diastolic pressures, as well as pulse rate, by the oscillometric method, with a telehealth system or for home use.
Device Description
The Bosch Blood Pressure Monitor (BP5000 BT) is an upper arm, non-invasive, blood pressure device, designed for home use. It is a simple device designed to measure a patient's systolic and diastolic pressures, as well as pulse rate using the oscillometric measuring method. The Bosch Blood Pressure Monitor (BP5000 BT) has a voice prompt function and a memory function. There are five available languages to choose from (US English, UK English. Spanish. French and German). The BP5000 BT can store up to 42 measurements, including their date and time stamp, in its memory. By pressing the memory button on the device, the last blood pressure measurement and pulse rate is displayed on the LCD screen and announced by the voice prompt. The volume can be adjusted by pressing the volume button. The Bosch Blood Pressure Monitor (BP5000 BT) is also designed to connect wirelessly, via Bluetooth, to a Bosch or Continua compliant telehealth patient interface. The connection is made automatically when the telehealth device prompts the patient to take their blood pressure measurement. Once the measurement is complete, the Bluetooth symbol on the blood pressure monitor will flash, indicating that the measurement is being transferred to the telehealth device. If Bluetooth is disabled, the BP5000 BT will store the measurements in its merhorv and will transmit all the stored data to the telehealth device once Bluetooth has been enabled.
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