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510(k) Data Aggregation

    K Number
    K081499
    Device Name
    HEALTH MANAGER, VERSION 1.1
    Date Cleared
    2009-01-16

    (232 days)

    Product Code
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    **BIOCOMFORT DIAGNOSTICS GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Brocomfort Health Manager is a software for local home PC or Laptop in a non clinical environment to collect historical data from defined peripheral devices The software will receive, store and display measurements from home use diagnostic medical devices such blood pressure meter and a body composition analyser The data will not be used for medical diagnosis It is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgement
    Device Description
    The Brocomfort Health Manager is a software for local home PC or Laptop in a non clinical environment HM can manage up to 8 users With the HM the Biocomfort devices can be bound with the USB-Dongle from Biocomfort After the devices are bound and programmed with HM, the user can measure with the devices
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    K Number
    K081498
    Device Name
    TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205
    Date Cleared
    2008-12-17

    (202 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    **BIOCOMFORT DIAGNOSTICS GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The tenso-comfort BPM 105 /BPM 205 is a wrist non-invasive blood pressure device which is intended for use in measuring blood pressure and pulse rate in adult patient population. The measuring method is an oscillometric blood pressure measurement with automatic sequence and refers to the auscultatory method as the reference standard. The model version BPM 105 is equipped with a radio module to transmit the measurement data to a PC. The device is not intended for neonatal use.
    Device Description
    The non-invasive wrist blood pressure meter BPM105 and BPM205 determine the arterial blood pressure by means of the oscillometric blood pressure measuring method. With this method the pressure fluctuations are measured, which develop when depressing pulse-cyclic blood pulses in the compressed arteria under the blood pressure cuff put on. The blood pressure apparatus in the model variant BPM105 is equipped with a radio module, with which the transmission of the stored measured values on a PC is optionally possible (radio interface for PC and software is offered as accessory).
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