(14 days)
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.
Not Found
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.
§ 868.1920 Esophageal stethoscope with electrical conductors.
(a)
Identification. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.(b)
Classification. Class II (performance standards).