K Number
K952712Device Name
WHITE RIVER BATTERY-POWERED BREAST PUMPManufacturer
Date Cleared
1996-04-18
(309 days)
Product Code
Regulation Number
884.5160Type
TraditionalPanel
OPReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 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).