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

    DRAGER DVE 4000 SERIES SYSTEM

    K Number: K921297 · Decision Nov 27, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    34
    Applicant Total
    10
    Review Days
    255

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    Basic Information

    Device Name
    DRAGER DVE 4000 SERIES SYSTEM
    K Number
    K921297
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4960
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alm Surgical Equipment, Inc.
    Date Received
    March 17, 1992
    Decision Date
    November 27, 1992
    Product Code
    FQO
    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
    FQO Table, Operating-Room, Ac-Powered

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    K961742 DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM
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    K942043 DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E
    K922409 ALM ILLUMINATOR SERIES LIGHT SYSTEM
    K921848 BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT
    K884019 ALM OPERATING TABLES
    K882613 ALM SURGICAL LAMPS