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510(k) Data Aggregation
K Number
K081499Device Name
HEALTH MANAGER, VERSION 1.1
Manufacturer
Date Cleared
2009-01-16
(232 days)
Product Code
Regulation Number
870.2910Why 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
K081498Device Name
TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205
Manufacturer
Date Cleared
2008-12-17
(202 days)
Regulation Number
870.1130Why 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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