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K Number
K131027
Device Name
MEMORY PUMP MODEL Y4947
Manufacturer
TOMY INTERNATIONAL
Date Cleared
2013-05-30

(48 days)

Product Code
HGX
Regulation Number
884.5160
Type
Traditional
Panel
OB
Reference & 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.

§ 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).