BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MERIDIAN DSP

    K Number: K972431 · Decision Jul 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    5
    Review Days
    29

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    Basic Information

    Device Name
    MERIDIAN DSP
    K Number
    K972431
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Micro-Ear Technology, Inc.
    Date Received
    June 24, 1997
    Decision Date
    July 23, 1997
    Product Code
    ESD
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ESD Hearing Aid, Air-Conduction, Prescription

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    Other Clearances by Micro-Ear Technology, Inc.

    K Number Device Name
    K041302 REFUGE SOUND GENERATOR
    K970880 POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN
    K964657 SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF
    K934149 MICRO-TECH TRU CANAL