BEUDAMED
    Product Code: ETF FDA class 1 21 CFR 874.5300

    Unit, Examining/Treatment, Ent

    Ear, Nose, Throat

    The ENT examining and treatment unit is an integrated clinical workstation combining lighting, suction, and instrumentation to support diagnostic examination and minor treatment procedures in the ear, nose, and throat specialty. It is classified as FDA Class 1, the lowest risk category, requiring only general controls and no premarket submission. The product code is ETF, regulated under 21 CFR 874.5300 in the Ear, Nose, Throat specialty. No special regulatory flags apply.

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    510(k)s
    32
    FEI Numbers
    25
    Registration Numbers
    25
    Unique Applicants
    13
    Years Active
    17

    Basic Information

    Product Code
    ETF
    Device Class
    FDA class 1
    Regulation Number
    874.5300
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    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 32 510(k) clearances via K numbers.

    K Number Device Name
    K953457 JEDMED SPECTRUM ENT CABINET
    K945395 PREMIER MIRROR WARMER
    K932470 LANGGASSE 90
    K911901 MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE
    K910781 #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES
    K910243 MOBILE TREATMENT CART
    K896298 JEDMED S CHAIR
    K896273 SYSTEMA ENT CABINET
    K881958 JEDMED MAXIM ENT CABINET
    K860940 MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT
    K855021 LARYNGEAL MIRROR PRE-WARMER
    K843046 RELIANCE TREATMENT CABINET
    K833882 INSTRUMENT CABINET
    K823226 SN-100 DOCTOR'S ROUND
    K822252 ENT TREATMENT UNITS
    K822531 MULTIPLE, ENT CABINET #448
    K822530 MULTIPLE, ENT CHAIR #418
    K822016 NAGASHIMA SN-SP UNIT AND CHAIR
    K813490 VERSION OF A CLOSED-FLOW SYS. CALORIC
    K810148 ATMOSET
    K802712 ENTERMED ENTUNIT
    K801742 NEW FINE MODEL ENT TREATMENT UNIT
    K801741 PRETTY MODEL ENT TREATMENT UNIT
    K801740 TREATMENT UNIT FOR DOCTOR'S ROUNDS
    K801739 NOBLE MODEL DOUBLESIDED TREATMENT UNIT
    K801738 NOBLE MEDEL ENT TREATMENT UNIT
    K800756 DUNRICH TABLES
    K800526 SMR H-CHAIR
    K791936 ATMOS ENT CABINET PRACTICA 2
    K791935 ATMOS ENT CABINET PRACTICA 3
    K791934 ATMOS ENT TREATMENT SYSTEM SERVANT 3
    K782064 TABLE, EXAMINING-TWO EIGHTY

    FEI Numbers

    This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.