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510(k) Data Aggregation
K Number
K223509Device Name
Compremium Compartment Compressibility Monitoring System (CPM#1)
Manufacturer
Compremium AG
Date Cleared
2023-04-14
(143 days)
Product Code
LXC
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Compremium AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Compartmental Compressibility Monitoring System (CPM#1) is intended for real-time and intermittent monitoring of relative compartment compressibility.
The relative compartment compressibility (CP Value) is not meant for trend analysis.
Device Description
The Compartmental Compressibility Monitoring System (CPM#1) is a point-of-care device for non-invasive, real-time, and intermittent monitoring of relative compartment compressibility.
The device combines a linear ultrasound array with an integrated pressure sensor into a single handheld probe (CP Probe) to obtain cross-section ultrasound views of the compartment of interest. The device provides a surrogate metric of the compartment's compressibility in one ultrasound image plane only, using a linear measurement of distance between two points of the compartment, as a function of applied external pressure.
Based on this measurement, a relative compartment compressibility value is calculated and displayed on-screen as the CP Value.
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