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510(k) Data Aggregation
K Number
K143304Device Name
Sickbay Clinical Platform
Manufacturer
Date Cleared
2015-05-26
(189 days)
Product Code
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
Medical Informatics Corp
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sickbay Clinical Platform is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Electronic Medical Record (EMR) and Clinical Information Systems.
The Sickbay Clinical Platform is a remote monitoring platform that displays physiologic data, waveforms and alarms routed through the Sickbay Clinical Platform for supported devices. The Sickbay Clinical Platform is intended to be used by healthcare professionals in a hospital setting for the following purposes:
- To remotely consult, regarding a patient's status .
- To remotely review other standard or critical near real-time patient data, . waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
WARNING: The Sickbay Clinical Platform is intended to supplement and not to re-place any part of the hospital's device monitoring. Do not rely on the Sickbay Clinical Platform product as the sole source of alarms.
Note: Sickbay Clinical Platform product includes 3 Apps: Patient Monitoring App; Patient Alarm Data Monitor & Alarm Analytics Dashboard App.
Device Description
Medical Informatics Corp (MIC) has developed a software platform and analytics engine, Sickbay™, which gathers physiological data streams coming from patient monitoring devices and other clinical data sources. Medical Informatics Corp's software platform, Sickbay, captures patient data and enables near real-time display and analytics for clinicians to use in clinical decision support.
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