(108 days)
The Model SUA01 Suction unit is intended for professional use to remove infectious materials from wounds or fluids from a patients airway or respiratory support unit. The intended large population for this device is both adult and pediatric patients.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, study details, or device performance metrics for the "Model SUA01 Suction Unit". The document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a predicate device and allows the device to be marketed. It states the indications for use but does not contain a study report or technical specifications with performance data.
Therefore, I cannot provide the requested table and study details.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.