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510(k) Data Aggregation
K Number
K153079Device Name
Axeo 3 Patient Monitor
Manufacturer
Date Cleared
2016-03-17
(146 days)
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
AXEO MEDICAL TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The purpose and function of the AXEO 3 patient monitor basic physiological parameters including
- · ECG waveform derived from 3 or 5 lead measurements
- · Heart Rate
- · NIBP (systolic, diastolic, and mean arterial pressure)
- · SpO2
- · Respiration
- · Temperature up to 2 channels (Dual Temperature)
The target population is for adult, neonate and pediatric patients. It may be used as bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
This device is not intended for use as an apnea monitor.
Prescription Use: Federal law restricts this device to sale by or on the order of a physician.
Device Description
The Axeo 3 Patient Monitor is a comprehensive monitoring system with up to 8 traces compiling, processing, and displaying data from up to six different parameters: ECG. Heart Rate. NIBP. SoO2. Respiration, and Temperature. It integrates parameter measuring modules, a display, and a recorder in one device, featuring compactness, light weight, and portability.
A built-in rechargeable battery facilitates off-AC-power transport of the patient providing at monitoring from a fully charged battery. The battery recharges when AC power is reconnected to the monitor.
The associated accessories include:
- ECG Cable
- . SpO2 Finger Probes
- . Blood Pressure Cuffs
- Temperature Probe ●
- . Power Supply with Power Cord
- . User's Manual
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