Search Results
Found 1 results
510(k) Data Aggregation
K Number
K131272Device Name
SIREN EPCR SUITE
Manufacturer
Date Cleared
2014-01-03
(245 days)
Regulation Number
870.2450Why did this record match?
Applicant Name (Manufacturer) :
MEDUSA MEDICAL TECHNOLOGIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Siren ePCR Suite™ is intended for the collection, storage and printing of patient data that is entered by a user (paramedic), or captured from specified medical devices, and integrated into a patient care report (patient electronic medical record). Siren ePCR Suite™ is intended for use by qualified medical personnel providing direct patient care in the pre-hospital environment to document the care provided. Siren ePCR Suite™ is indicated for use by health care providers whenever there is a need for generation of a patient record.
Device Description
Siren ePCR Suite™ is a software-only product. Siren ePCR Suite™ is a medical data collection system used to collect, store and print patient data that is entered by a user (caregiver), or captured from specified medical devices, and is integrated into a patient care report (patient electronic medical record). Siren ePCR Suite™ is non-alarming software that runs on a variety of commercial off-the-shelf hardware.
Ask a Question
Ask a specific question about this device
Page 1 of 1