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510(k) Data Aggregation
K Number
K101133Device Name
SENSOMETRICS SOFTWARE
Manufacturer
Date Cleared
2010-11-18
(210 days)
Product Code
Regulation Number
882.1620Why did this record match?
Applicant Name (Manufacturer) :
DPCOM AS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sensometrics Software is intended for use by a qualified nurse or physician to display variables from existing legally marketed primary measuring devices used to monitor neurosurgical and neurological patients. The parameters displayed by the Sensometrics Software include intracranial pressure, arterial blood pressure, oxygen, core/cerebral temperature, and these are continuously trended in charts. The presentation of both measured parameters and the relationships between them is intended as an adjunct to the information provided by existing primary monitors. The Sensometrics® Software should not be used alone as the sole basis for decisions as to diagnosis or therapy.
Device Description
Sensometrics® Software is a secondary display system that collects together on a single large color display screen the measured pressure variables relevant to the multimodality monitoring of the patient in a neurosurgical intensive care unit. It receives digital inputs from primary monitors used in the measurement of intracranial pressure, arterial blood pressure and cerebral temperature. The Sensometrics® Software displays the measured and derived variables in digital trace form and can store and display trends over periods of up to 240 hours.
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