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

    PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS

    K Number: K012804 · Decision Jan 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    42
    Applicant Total
    1
    Review Days
    149

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS
    K Number
    K012804
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5970
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scott E Allen CP
    Date Received
    August 21, 2001
    Decision Date
    January 17, 2002
    Product Code
    MVA
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MVA Orthosis, Cranial

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MVA), ordered by most recent decision date.

    Talee, Talee PostOp

    FDA 510(k)
    FDA Class 2 ·Neurology

    Talee, Talee PostOp

    FDA 510(k)
    FDA Class 2 ·Neurology

    STARband 3D

    FDA 510(k)
    FDA Class 2 ·Neurology

    Talee, Talee PostOP

    FDA 510(k)
    FDA Class 2 ·Neurology

    Hanger Cranial Band 3D

    FDA 510(k)
    FDA Class 2 ·Neurology

    MyCRO Band

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all