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510(k) Data Aggregation
K Number
K013116Device Name
DURQ/ QUALIDURA
Manufacturer
Date Cleared
2002-01-18
(122 days)
Product Code
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
EVER-SAFETY TECHNICAL SERVICE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
Device Description
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.
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