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The intended use of the temperature probes is to measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable. These probes have skin or core contact with a patient.

Skin probe (SSP 400 and SSP 700): The Skin Sensor Probe is indicated for use in the routine monitoring of skin temperature. It is individually packaged. The skin temperature probe is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.

GP Probes (GP 9400, GP 9700 and GP 14400): The General Purpose Temperature Probe is intended for continuous temperature monitoring. The probe is inserted into the nasopharynx, mouth or the rectum. It is individually packaged. The temperature probe beneath the cuff at the distal tip is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.

Tympanic Probe (TP 400 and TP 700: The Tympanic Probe is intended for monitoring patient temperature through the outer auditory ear canal. It is individually packaged. The tympanic Probe is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.

The intended use of the temperature probes is to measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable. These probes have skin or core contact with a patient.

This document is an FDA 510(k) clearance letter for temperature probes and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria. It states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide accurate answers to the questions based on the provided text. The document refers to the general controls provisions of the Act, which cover manufacturing practices, labeling, and other regulations, but it does not detail specific performance acceptance criteria or study methodologies.

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The intended use of the esophageal stethoscope is to listen to heart and breath sounds while a patient is under anesthesia. Additionally, patient temperature can be monitored using the stethoscopes with 400 or 700 series thermistors. The stathoscopes are provided "packaged clean" and are for "single use" only.

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The provided document is a 510(k) clearance letter from the FDA for an Esophageal Stethoscope. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for market clearance based on its similarity to existing devices. This typically involves demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device.

Therefore, I cannot provide the requested information about acceptance criteria or a study from the given text. This type of information would typically be found in the 510(k) submission itself, or in associated test reports, which are not part of this FDA clearance letter.

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