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510(k) Data Aggregation
K Number
K982384Device Name
MERCATOR
Manufacturer
HARLEY STREET SOFTWARE LTD.
Date Cleared
1999-01-27
(203 days)
Product Code
DSH
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
HARLEY STREET SOFTWARE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mercator is intended to be used as a data management tool for physicians and cardiac clinics to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices. Users will be able to purchase specific modules for managing other patient cardiac related data such as pacemaker and rehabilitation data that fit their patients' needs. Mercator is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. Mercator does not offer diagnosis or medical alarms.
Device Description
Mercator is a software product designed for the Microsoft Windows 95 and Microsoft Windows NT operating systems running on an IBM compatible platform. Mercator consists of a user interface that enables health care professionals to input, store, and output data from a relational database.
The product consists of a set of modules that can be "plugged in" to customize the application to individual users' needs.
Mercator is capable of multi-tasking and supports the linking and embedding of related information objects in the ECG. The software supports many aspects of a patient's cardiology record including: arrhythmia diagnosis, pathological diagnosis, ECGs, ECG information, doctor notes, pacemaker/ICD data and associated reports. Mercator also supports appointment scheduling and stores information on physicians, facilities, allied health care professionals, and insurance providers.
Mercator is not a life-supporting or life-sustaining system. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.
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