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510(k) Data Aggregation

    K Number
    K080735
    Device Name
    CRYOMINI
    Manufacturer
    ZIMMER ELEKTROMEDIZIN GMBH
    Date Cleared
    2008-04-04

    (18 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZIMMER ELEKTROMEDIZIN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CryoMini Cold Air Device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
    Device Description
    The CryoMini consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.
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    K Number
    K060395
    Device Name
    CRYO, MODEL V6.0
    Manufacturer
    ZIMMER ELEKTROMEDIZIN GMBH
    Date Cleared
    2006-02-24

    (9 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZIMMER ELEKTROMEDIZIN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cryo V6.0 Cold Air Device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
    Device Description
    The Cryo V6.0 consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.
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    K Number
    K040727
    Device Name
    CRYO 5
    Manufacturer
    ZIMMER ELEKTROMEDIZIN GMBH
    Date Cleared
    2004-04-23

    (32 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZIMMER ELEKTROMEDIZIN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cryo 5 Cold Air Device is intended, to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
    Device Description
    The Cryo 5 consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.
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    K Number
    K960969
    Device Name
    GALVA 5-T
    Manufacturer
    ZIMMER ELEKTROMEDIZIN GMBH
    Date Cleared
    1996-05-15

    (65 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZIMMER ELEKTROMEDIZIN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K952536
    Device Name
    SONO 5
    Manufacturer
    ZIMMER ELEKTROMEDIZIN GMBH
    Date Cleared
    1996-03-05

    (278 days)

    Product Code
    IMI
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZIMMER ELEKTROMEDIZIN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K954411
    Device Name
    GALVA-5-M
    Manufacturer
    ZIMMER ELEKTROMEDIZIN GMBH
    Date Cleared
    1996-02-28

    (160 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZIMMER ELEKTROMEDIZIN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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