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510(k) Data Aggregation
K Number
K161532Device Name
Philips Avent Comfort Single/Twin Electric Breast Pump
Manufacturer
Philips Consumer Lifestyle-Innovation Site Eindhoven
Date Cleared
2016-08-29
(88 days)
Product Code
HGX, POW
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Philips Consumer Lifestyle-Innovation Site Eindhoven
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Philips Avent Comfort Single/Twin Electric Breast Pump is intended to express and collect milk from the breast of a lactating woman. The device is intended for a single user.
Device Description
The subject devices are electrically powered single (Comfort Single) and double (Comfort Double) breast pumps consisting of a motor and pump body, press-button user interface, and collection kit. A vacuum pump creates a vacuum at the breast of the lactating woman. This vacuum is released after a short period of time. By repeating this behavior, a cyclic vacuum generation pattern is created which enables expressing of milk from the breast. The expressed milk will be collected in the container which can be used for storage. The breast pump supports different operating modes: stimulation, expression 1, expression 2 and expression 3. The stimulation mode is entered upon start of the device when suction is felt on the breast. Once the milk starts flowing an expression mode may be chosen that has the most comfort, e.g. the combination of rhythm and suction level.
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