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510(k) Data Aggregation
K Number
K151781Device Name
Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
Manufacturer
Date Cleared
2016-05-27
(331 days)
Product Code
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
IVY BIOMEDICAL SYSTEMS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ivy Biomedical Model 7810 ("7810") is a basic cardiac monitor used to provide cardiac and respiratory trigger pulse outputs used by third-party systems that require ECG or respiratory synchronization. Cardiac and respiratory synchronization is commonly used in diagnostic imaging modalities (i.e., nuclear medicine, computed axial (CAT), or positron emission (PET) tomography) or other applications requiring such synchronization.
The 7810 is intended for use in pediatric and adult patients undergoing diagnostic imaging and related procedures in inpatient and outpatient centers under the supervision of licensed healthcare professionals.
The product is not intended for use as a life support, home monitoring, or magnetic resonance imaging (MRI) modality.
Device Description
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