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

    HS AMICA

    K Number: K083157 · Decision Sep 29, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    67
    Applicant Total
    6
    Review Days
    340

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    Basic Information

    Device Name
    HS AMICA
    K Number
    K083157
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    H.S Hospital Service S.P.A
    Date Received
    October 24, 2008
    Decision Date
    September 29, 2009
    Product Code
    NEY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NEY System, Ablation, Microwave And Accessories

    Similar 510(k) Clearances

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    Other Clearances by H.S Hospital Service S.P.A

    K Number Device Name
    K242029 TRAP EASY
    K232072 AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G
    K182605 HS AMICA devices family
    K150112 HS AMICA DEVICES FAMILY
    K033616 TRAPMATIC SYSTEM SET