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510(k) Data Aggregation
K Number
K963415Device Name
VENTREX OXYGEN SENSOR
Manufacturer
Date Cleared
1996-11-25
(87 days)
Product Code
Regulation Number
868.1720Why did this record match?
Applicant Name (Manufacturer) :
VENTREX, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Each device has similar intended uses. The VENTREX line of oxygen sensors and predicate devices have similar clinical applications. Each is used to determine the amount (expressed as % O2) of oxygen present in an atmosphere.
Device Description
The VENTREX line of oxygen sensors are medical devices which produce an electrical current which is directly proportional to the amount of oxygen contained in a gas mixture. Like any oxygen sensor, the VENTREX oxygen sensor electrical out-put must be interpreted by an electronic monitoring instrument. As is the case with all oxygen sensors, the VENTREX sensors will be used in the hospital, in physician offices, out-patient care centers, extended care facilities, homes, emergency medical services and patient transport.
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