(56 days)
Ambu Suction Pump is intended for quick suction of fluids from the nose and mouth of children and adult as well as for amnionic fluids from the newborn.
Not Found
This is a 510(k) clearance letter from the FDA for a medical device. It does not include information on acceptance criteria or a study proving the device meets those criteria. Such information would typically be found in the 510(k) submission itself, not the clearance letter.
Therefore, I cannot provide the requested information based only on the provided text. The document confirms the device is substantially equivalent to a predicate device, which is the basis for its market clearance, but doesn't detail performance studies or acceptance criteria it might have undergone.
§ 868.6810 Tracheobronchial suction catheter.
(a)
Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.(b)
Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.