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510(k) Data Aggregation
K Number
K001317Device Name
ARIA
Manufacturer
DEL MAR MEDICAL SYSTEMS, LLC.
Date Cleared
2000-07-21
(86 days)
Product Code
MWJ
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
DEL MAR MEDICAL SYSTEMS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993620Device Name
IMPRESARIO
Manufacturer
DEL MAR MEDICAL SYSTEMS, LLC.
Date Cleared
1999-11-12
(17 days)
Product Code
DQK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
DEL MAR MEDICAL SYSTEMS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Impresario™ software is intended for the analysis, summary and reporting of prerecorded ambulatory ECG data. At the requirement of a clinician, ambulatory ECG data is recorded in analog or digital form for up to 48 hours in multiple channels. The resultant recordings are segregated into a series of reports presenting significant clinical events as defined by the system, and affirmed by the review and confirmation of a clinician. The system is employed as a screening tool to record ECG events and to present these events to a qualified clinician review, edit and assessment.
Device Description
Impresario is an arrhythmia analysis software system that allows the customer to purchase software only and install it on his/her computer. It is compatible with all Del Mar ambulatory ECG (Holter) recorders. It provides 3-channel automated arrhythmia analysis with operator intervention and edit. Reports include summary, totals, trends, histograms, and full disclosure.
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