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

    ALM SURGICAL LAMPS

    K Number: K882613 · Decision Jul 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    28
    Applicant Total
    10
    Review Days
    24

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    Basic Information

    Device Name
    ALM SURGICAL LAMPS
    K Number
    K882613
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Alm Surgical Equipment, Inc.
    Date Received
    June 24, 1988
    Decision Date
    July 18, 1988
    Product Code
    FTD
    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
    FTD Lamp, Surgical

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    Other Clearances by Alm Surgical Equipment, Inc.

    K Number Device Name
    K982063 ALM PRISMALIX (PRX) SURGICAL LIGHT
    K961886 DRAGER GEMINA WALL-MOUNTED WORKPLACE
    K961742 DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM
    K945102 MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE
    K942043 DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E
    K922409 ALM ILLUMINATOR SERIES LIGHT SYSTEM
    K921297 DRAGER DVE 4000 SERIES SYSTEM
    K921848 BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT
    K884019 ALM OPERATING TABLES