(122 days)
The ELECTRIC NOSE VACUUM IS designed to improve the disadvantages of the conventional rubber bulb type aspirators with poor suction power , unstable and hard to use. Now no more squeezing by hands or suction by mouth. It removes nasal mucus and fluids from baby's nostrils at home safely and easily.
The device is an Electric Nose Vacuum (Aspirator) Model No : 02001. It is a powered pump aspiration device. It consists of a silicone rubber nozzle, a collection cup made of PC, a TPR button, and an enclosure made of ABS. The internal components include a Pump Body made of POM, a DC Motor (Mabuchi Motor Co., Ltd., Cat. No. : RE-280SA-2865) operating at 1.5 V - 4.5 V DC, and a DC Momentary Start Switch (Sweeta Products Corporation Cat. No. : PS-22F05) rated at 50 V DC 0.3 A. It is powered by a 4.5 V DC Power Supply and has a vacuum pressure of 0- 45 kpa.
The provided text focuses on the 510(k) summary for the Durq Electric Nose Vacuum (Aspirator) and does not contain information about acceptance criteria or a study proving its performance against such criteria. The document is primarily an administrative submission to the FDA, detailing the device's classification, intended use, and materials for substantial equivalence.
Therefore, I cannot fulfill your request for information about acceptance criteria and a study proving the device meets them based on the provided text.
§ 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.