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

    ALM PRISMALIX (PRX) SURGICAL LIGHT

    K Number: K982063 · Decision Sep 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    73
    Applicant Total
    10
    Review Days
    102

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    Basic Information

    Device Name
    ALM PRISMALIX (PRX) SURGICAL LIGHT
    K Number
    K982063
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alm Surgical Equipment, Inc.
    Date Received
    June 12, 1998
    Decision Date
    September 22, 1998
    Product Code
    FSY
    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
    FSY Light, Surgical, Ceiling Mounted

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    Other Clearances by Alm Surgical Equipment, Inc.

    K Number Device Name
    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
    K882613 ALM SURGICAL LAMPS