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510(k) Data Aggregation
K Number
K171056Device Name
WAVE Clinical Platform
Manufacturer
Date Cleared
2018-01-04
(269 days)
Product Code
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
Excel Medical Electronics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The WAVE Clinical Platform is software intended to route, store, and display data, alarms, results and diagnostic information from medical devices, Electronic Medical Records (EMR), and Clinical Information Systems (CIS).
The WAVE Clinical Platform is a remote monitoring platform that displays physiologic data, waveforms, alarms, results and diagnostic information routed the WAVE Clinical Platform from supported devices and systems. The WAVE Clinical Platform is intended for use in hospital type environments. The WAVE Clinical Platform is intended to be used by healthcare professionals for the following purposes:
· To remotely consult regarding patients' statuses:
· To remotely review other standard or critical near real-time patient data, waveforms, and results in order to utilize this information to aid in clinical decisions.
Warning: The WAVE Clinical Platform is intended to supplement and not to replace any part of the hospital's device monitoring or electronic data management systems. Do not rely on the WAVE Clinical Platform product as the sole source of alarms.
Device Description
Excel Medical's WAVE Clinical Platform is a software platform that gathers and stores data from patient monitoring and other medical devices, hospital information systems, and clinical analytics data sources for near real-time and retrospective remote display for clinicians to use in clinical decision support. The WAVE Clinical Platform can also route and forward these data to third party systems.
The WAVE Clinical Platform can utilize the hospital's existing network and hardware for installation and display on any device that is web-enabled. The WAVE Clinical Platform does not control any of the medical devices or systems it is connected with.
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