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510(k) Data Aggregation
K Number
K061590Device Name
SMDIE DEVICE INTERFACING SYSTEM
Date Cleared
2006-06-21
(13 days)
Product Code
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS MEDICAL SOLUTIONS HEALTH SERVICES CORPORAT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SMDIE Device Interfacing System is indicated for data transfer between standalone physiological monitors that collect noninvasive blood pressure, temperature, and blood oxygenation level through external cuffs and thermometers to external clinical information systems. The SMDIE is also indicated for patient weight transfer between Scale-Tronix 5002 class physician office scales. The SMDIE Device Interfacing System is not intended for continuous vital sign monitoring purposes.
Prescription Use
Device Description
The SMDIE Device Interfacing System Software is intended for use with standalone physiological monitor and Scale-Tronix 5002 scales to transfer data from the physiological monitor and scale to external devices via Health Level Seven data exchange protocols for vitals results and patient information.
Serial interfaces between physiological monitors and the SMDIE allow patient weight, non-invasive blood pressure, blood oxygenation level, and temperature to be communicated to the Device Connectivity & User Interface Component.
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