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510(k) Data Aggregation

    K Number
    K962767
    Device Name
    MS401097-17,MS722-K,MS720,MS721,MS722
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-07-03

    (352 days)

    Product Code
    HLJ
    Regulation Number
    886.1570
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K832437
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Replacement battery for Site Micro Surgical Systems (Keeler Optical) 1919-P-5020 Medic Lux 1919-P-5020, 510(k) Number K832437.

    This battery is shipped only to customers who request a replacement battery for a particular device or to the biomedical equipment technician therefore knows the intended use is as a replacement battery.

    Device Description

    Rechargeable Batteries (Part Numbers Trade Name: MS401097-17, MS720, MS721, MS722, and MS722-K)

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for rechargeable batteries (Trade Name: MS401097-17, MS720, MS721, MS722, and MS722-K). It declares the substantial equivalence of these devices to legally marketed predicate devices.

    The provided document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria for a medical device that would typically involve performance metrics like sensitivity, specificity, or reader studies.

    The letter focuses on regulatory clearance based on substantial equivalence to existing devices, not on a detailed analysis of performance metrics. Therefore, I cannot generate the requested information based on the input document.

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