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arterial blood gassing monitoring system abg
Migada
Summary: The arterial blood gassing monitoring system ABG by Migada is used for monitoring arterial blood gases. It is FDA 510k cleared and linked to studies on cerebral blood flow and skin flap perfusion.
FDA Clearance Information
Pathway
510K
Number
K870016 ↗
Decision Date
May 28, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The arterial blood gassing monitoring system ABG was cleared by the FDA through the 510k pathway on May 28, 1987. It is manufactured by Migada and classified as a Class 3 device.
What It Is
The arterial blood gassing monitoring system ABG is designed to measure arterial blood gases, providing critical information on a patient's respiratory and metabolic status. It is intended for use in clinical settings where monitoring of blood gases is essential.
Clinical Applications
This device is commonly used in intensive care units, operating rooms, and emergency departments to monitor patients' arterial blood gases. It aids in the management of patients with respiratory or metabolic disorders.
Evidence Summary
The available literature includes two studies from 1991 and 1996. These studies explore the mechanisms of cerebral blood flow control and skin flap perfusion, respectively, using related methodologies.
Reported Outcomes
Published studies report on the mechanisms of controlling regional cerebral blood flow in epilepsy and the perfusion techniques in human skin flaps. However, specific efficacy outcomes related to the arterial blood gassing monitoring system ABG are not detailed in the provided studies.
Safety Profile
Reported complications include potential issues related to the perfusion techniques in isolated human skin flaps. No specific adverse events related to the arterial blood gassing monitoring system ABG are detailed in the provided studies.
Evidence Limitations
The evidence provided does not directly address the efficacy or safety of the arterial blood gassing monitoring system ABG. Further research is needed to establish specific outcomes and safety profiles for this device.
Frequently Asked Questions
What are the clinical indications for arterial blood gassing monitoring system ABG?
The device is indicated for monitoring arterial blood gases in clinical settings, as per FDA documentation.
What outcomes have been reported in clinical studies?
The studies provided focus on cerebral blood flow and skin flap perfusion, without specific outcomes for the arterial blood gassing monitoring system ABG.
What complications have been reported?
Safety data from the studies mention potential issues with perfusion techniques, but no specific complications for the arterial blood gassing monitoring system ABG are reported.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.