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

    PHILIPS M60 SERIES

    K Number: K920142 · Decision Jan 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    11
    Review Days
    10

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    Basic Information

    Device Name
    PHILIPS M60 SERIES
    K Number
    K920142
    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
    Philips Int'L B.V.
    Date Received
    January 13, 1992
    Decision Date
    January 23, 1992
    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 Philips Int'L B.V.

    K Number Device Name
    K920134 PHILIPS 41 SERIES RAINBOW
    K852348 PHILIPS SOLARIUM HP 3134
    K851534 PHILIPS UV-A SOLARIUM TYPE HP 3150
    K851536 PHILIPS UV-A SOLARIUM TYPE HP 3141
    K851535 PHILIPS UV-A SOLARIUM TYPE HP 3140
    K851533 PHILIPS UV-A SDARIUM TYPE HP 3148(CFR 21 SUNLAMP
    K850206 PHILIPS UV-A SOLARIUM TYPE HP 3126-SUNLAMP
    K850205 PHILIPS UV-A SOLARIUM TYPE HP 3127-SUNLAMP
    K850203 PHILIPS UV-A SOLARIUM TYPE HP 3016-SUNLAMP
    K850204 PHILIPS UV-A SOLARIUM TYPE HP 3130-SUNLAMP
    Search all 11 clearances from Philips Int'L B.V. →