BEUDAMED
    Product Code: FQO FDA class 1 21 CFR 878.4960

    Table, Operating-Room, Ac-Powered

    General, Plastic Surgery

    An AC-powered operating room table is an electrically adjustable patient support surface used to position patients during surgical procedures. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FQO, regulated under 21 CFR 878.4960, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

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    510(k)s
    35
    FEI Numbers
    66
    Registration Numbers
    66
    Unique Applicants
    23
    Years Active
    41

    Basic Information

    Product Code
    FQO
    Device Class
    FDA class 1
    Regulation Number
    878.4960
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 35 510(k) clearances via K numbers.

    K Number Device Name
    K240598 Maestro System (REF100)
    K221410 Maestro Platform
    K090136 STERIS CMAX XLT SURGICAL TABLE
    K972810 OPT80 THE TRANSPORTABLE (OPT80)
    K971988 ALLEN, ULTRA AND SMART SOCKETS
    K971307 AMSCO SURGICAL TABLE
    K963506 TENET RADIOLUCENT HAND TABLE
    K961886 DRAGER GEMINA WALL-MOUNTED WORKPLACE
    K961742 DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM
    K955750 TELETOM
    K953980 KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT
    K951854 LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY
    K950192 SKYTRON SKYBOOM SERIES
    K926463 RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES
    K942486 IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE
    K942043 DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E
    K941150 MDT SHAMPAINE 5100B AND 5100E SURGICAL TABLES
    K940068 STRYKER OPERATING ROOM TABLE
    K936308 ENDEX ENDOSCOPIC POSITIONING SYSTEM
    K926525 BETASTAR 1131.02 MOBILE OPERATING TABLE
    K930493 QUANTUM 3080 SURGICAL TABLE
    K932186 BYPASS LEG POSITIONER
    K924700 FISK HEADREST
    K921297 DRAGER DVE 4000 SERIES SYSTEM
    K921143 PNEUMO-WEDGE
    K920890 OPERATING TABLE SYSTEM-BETAMAQUET 1140
    K922371 SPINAL POSITIONING FRAME
    K921626 TELETOM(R)
    K915141 712 PLASTIC SURGERY TABLE & ACCESORIES
    K882660 GENERAL SURGICAL TABLE AND ACCESSORIES
    K880227 ARTHROBOT(TM) LOWER LIMB POSITIONER
    K864325 DR7700 OPERATING TABLE
    K864295 DR.500O OPERATING TABLE
    K841115 CHARLES/MCINTYRE GIANT BREAK TABLE
    K831086 CEILING MOUNTED SUPPORT

    FEI Numbers

    This FDA classification entry is associated with 66 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 66 registration numbers. Click on an entry to view related FDA registrations.