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510(k) Data Aggregation
K Number
K131027Device Name
MEMORY PUMP MODEL Y4947Manufacturer
Date Cleared
2013-05-30
(48 days)
Product Code
Regulation Number
884.5160Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Memory Pump (double electric breast pump) is a single user device designed to express and collect milk from the breast.
Device Description
Not Found
AI/ML Overview
I am sorry. This document is a 510(k) premarket notification decision letter from the FDA regarding a breast pump. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements. Therefore, I cannot extract the requested information from the provided text.
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