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510(k) Data Aggregation
K Number
K173895Device Name
Tel-O-Graph
Date Cleared
2019-05-16
(511 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
I.E.M. Industrielle Entwicklung and Medizintechnik
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Tel-O-Graph is intended for the home measurement of blood pressure and pulse on the upper arm in adults. The blood pressure monitor is suitable for individuals with an arm circumference of 20-55 cm (7.9-21.7 in) when used with the corresponding monitor cuff size.
The data measured is automatically transmitted.
Device Description
The Tel-O-Graph is a table-top device for upper arm blood pressure measurements. The device employs the oscillometric principle for the non-invasive determination of the blood pressure from pressure signals obtained from the pressurized cuff placed around the upper arm. The device is operated via a single button to initiate blood pressure measurements. Data is transmitted automatically. The device is used by patients in a home environment.
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