BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BLOOD PRESSURE CUFF 3

    K Number: K951041 · Decision Oct 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    7
    Review Days
    239

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    Basic Information

    Device Name
    BLOOD PRESSURE CUFF 3
    K Number
    K951041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pedia Pals, Inc.
    Date Received
    March 6, 1995
    Decision Date
    October 31, 1995
    Product Code
    DXQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXQ Blood Pressure Cuff

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    Other Clearances by Pedia Pals, Inc.

    K Number Device Name
    K951040 BLOOD PRESSURE CUFF 2
    K951039 BLOOD PRESSURE CUFF 1
    K951049 SPECULUM, ENT (S3)
    K951050 SPECULUM, ENT (S3)
    K950086 PEDIA PALS, INCORPORATED
    K911650 PEDIA PALS