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K Number
K172842
Device Name
GCE704 Breast Pump
Manufacturer
Globalcare
Date Cleared
2018-06-18

(272 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 GCE704 Breast Pump is intended to express milk from the breasts of lactating women. The GCE704 Breast Pump is intended for a single user.

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the GCE704 Breast Pump. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The letter confirms the device's substantial equivalence to a legally marketed predicate device and outlines regulatory compliance requirements.

Therefore, I cannot provide the requested information based on the given input.

§ 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).