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K Number
K081932
Device Name
ENDEARE BREAST PUMP
Manufacturer
HYGEIA MEDICAL, INC.
Date Cleared
2009-01-22

(199 days)

Product Code
HGX
Regulation Number
884.5160
Type
Traditional
Panel
Obstetrics/Gynecology
Reference & Predicate Devices
K875300,K950750,K973501
Predicate For
K190465
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The EnDeare™ Breast Pump is indicated to express and collect milk from the breasts of lactating women

Device Description

The product is a powered breast pump with accessories that is used to express and collect milk from the breasts of lactating women

AI/ML Overview

The provided text is a 510(k) summary for the EnDeare™ Breast Pump. It does not contain any information about acceptance criteria or a study proving that the device meets those criteria, as it is a breast pump, not a diagnostic or AI-powered device.

Therefore, I cannot provide the requested information in the format specified. The document primarily focuses on demonstrating substantial equivalence to predicate breast pumps for regulatory clearance, rather than presenting performance data against a set of acceptance criteria.

§ 884.5160 Powered breast pump.

(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).