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510(k) Data Aggregation
K Number
K222712Device Name
Fogg System Patient Monitoring Cables
Manufacturer
Fogg System Company, Inc.
Date Cleared
2023-11-22
(440 days)
Product Code
DSA
Regulation Number
870.2900Why did this record match?
Applicant Name (Manufacturer) :
Fogg System Company, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Patient Monitoring Cables are intended to be used with SpO2, Temperature, BP, ECG, Cardiac Output, and related monitoring devices. The Patient Monitoring Cables are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring devices, or between monitoring devices, for general monitoring and/or diagnostic evaluation by health care professionals.
Device Description
The Patient Monitoring Cables are replacements for similar accessory cables manufactured or specified by Original Equipment Manufacturers (OEM) for their respective transducers, monitors, and peripheral equipment. These are non-patient-contact, insulated, electrical cables with a connector (plug or receptacle) at each end, designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect SpO2 sensor, IBP transducer to a patient monitor). They are not intended to connect to the mains (i.e., not mains power cables), do not generate any type of power and/or signal, and have no additional non-electrical conducting or processing functionality.
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