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

    SPECULUM, ENT (S3)

    K Number: K951050 · Decision Apr 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    228
    Same Product Code
    55
    Applicant Total
    7
    Review Days
    42

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    Basic Information

    Device Name
    SPECULUM, ENT (S3)
    K Number
    K951050
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4770
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pedia Pals, Inc.
    Date Received
    March 6, 1995
    Decision Date
    April 17, 1995
    Product Code
    ERA
    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
    ERA Otoscope

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    Other Clearances by Pedia Pals, Inc.

    K Number Device Name
    K951040 BLOOD PRESSURE CUFF 2
    K951039 BLOOD PRESSURE CUFF 1
    K951041 BLOOD PRESSURE CUFF 3
    K951049 SPECULUM, ENT (S3)
    K950086 PEDIA PALS, INCORPORATED
    K911650 PEDIA PALS