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510(k) Data Aggregation
K Number
K122063Device Name
INTELLISAVE AX700 ANESTHESIA SYSTEM
Manufacturer
Date Cleared
2013-08-02
(385 days)
Product Code
Regulation Number
868.5160Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS ANESTHESIA CARE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Intellisave AX700 Anesthesia System is intended to provide general inhalational anesthesia and ventilation support to neonatal, pediatric and adult patients. The device is intended to provide volume or pressure controlled ventilation.
Device Description
The Intellisave AX700 suitable for most types of inhalation anesthesia. O2 and N2O or O2 and Air can be administered, and anesthesia vaporizer(s) can be connected to a back bar. The gasses can be supplied from a centralized supply or cylinders. The Intellisave AX 700 is a prescriptive device restricted to use by, or on the order of, a physician. The Intellisave AX700 includes the following: An Electronic Gas Mixer (EGM), an anesthesia ventilator with various ventilation modes, an Integrated Breathing System (IBS), and an optional multigas module.
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