LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K082307
    Device Name
    EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT
    Manufacturer
    EVENFLO COMPANY, INC.
    Date Cleared
    2008-09-11

    (29 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Type
    Special
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Evenflo Comfort Select Performance Breast Pump and Comfort Select Performance Dual Breast Pump are personal use battery/electric-powered suction devices used to express milk from the breast/s of lactating women.

    Device Description

    Not Found

    AI/ML Overview

    This looks like a 510(k) clearance letter for a breast pump, not a scientific study describing acceptance criteria and device performance. Therefore, I cannot extract the requested information like sample size, ground truth, expert qualifications, or details about a comparative effectiveness study.

    The document states that the Evenflo Comfort Select Performance Breast Pump and Dual Breast Pump are for "personal use battery/electric-powered suction devices used to express milk from the breast/s of lactating women." It grants clearance based on substantial equivalence to a predicate device, not on meeting specific, detailed performance criteria from a clinical study described within this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1