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510(k) Data Aggregation

    K Number
    K971240
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-06-06

    (65 days)

    Product Code
    HEL
    Regulation Number
    884.2660
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K933687,K951403
    Why did this record match?
    Device Name :

    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006

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

    Replaces R&D Batteries part Number 5164 (K933687 and K951403) which are used in Sonicaid fetal heart monitors D100RE, D102R PN 1000-0006 K#873673.

    Device Description

    MOOlo Replacement Battery

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Alexander Manufacturing Company for a replacement battery, and an "Indications For Use" statement.

    Unfortunately, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    The letter is an FDA determination of substantial equivalence for a replacement battery (Part no. M006) to a predicate device, as required for marketing in the United States. It references previous 510(k) numbers for the devices the battery replaces.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is a regulatory approval letter, not a study report or technical specifications document.

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