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510(k) Data Aggregation
K Number
K033513Device Name
EASI ECG ALGORITHM
Manufacturer
PHILIPS MEDICAL SYSTEMS
Date Cleared
2004-01-15
(70 days)
Product Code
DRW
Regulation Number
870.2350Why did this record match?
Product Code :
DRW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EASI ECG is intended for monitoring multiple leads of ECG of adults, pediatrics and neonates. ST. Segment monitoring is restricted to adult patients only.
EASI ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult, pediatric, or neonatal patients including arrhythmia monitoring or ST segment changes of adult patients, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms, including:
- Assessment of symptoms that may be related to rhythm disturbances of the heart
- -Patients with palpitations
- The evaluation of arrhythmias in patients from neonatal to pediatric to adult age
- arrhythmia
- -- Assessment of efficacy of anti-arrhythmic therapy
- -- Assessment of pacemaker function
- Assessment of symptomatic or asymptomatic patients, to evaluate for, ischemic heart disease and arrhythmia analysis during exercise testing
Device Description
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K Number
K020456Device Name
EASI 12 LEAD ALGORITHM
Manufacturer
PHILIPS MEDICAL SYSTEMS
Date Cleared
2002-07-09
(148 days)
Product Code
DRW, 74D
Regulation Number
870.2350Why did this record match?
Product Code :
DRW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Assessment of real time ST segment analysis in adult patients. Assessment is indicated for the hospital environment.
Device Description
The new device is a modification to previously reviewed submittals containing the EASI algorithm. The modification is a software-based change that slightly improves existing correlation coefficients. The modification also allows reconstruction to simulate a Mason Likar lead placement.
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