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510(k) Data Aggregation
K Number
K131153Device Name
EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
Manufacturer
Date Cleared
2013-06-18
(55 days)
Product Code
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
EVENFLO FEEDING INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Evenflo Advanced Double Electric Breast Pump is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. This is for a single user.
Device Description
The Evenflo Advanced Double Electric Breast Pump is an electrically powered breast pump that uses negative pressure to express milk from a lactating woman's breasts. A reciprocating vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels between 25 and 254 mmHg. The flange system is convertible between single and double pumping. Four buttons on the user interface allow the user to select one of 32 settings (eight vacuum levels and four cycle rates for each vacuum level) and the LED interface displays the selected setting. Additionally, there are three different flange sizes that allow the user to select the size that best fits their breasts. These features allow the user to customize the device, improving the comfort of their pumping experience. The device can be powered by six "AA" batteries or the provided mains adapter.
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