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

    AMBU PORTABLE SUCTION UNIT

    K Number: K932031 · Decision May 5, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    33
    Review Days
    738

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    Basic Information

    Device Name
    AMBU PORTABLE SUCTION UNIT
    K Number
    K932031
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ambu, Inc.
    Date Received
    April 27, 1993
    Decision Date
    May 5, 1995
    Product Code
    BTA
    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
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Ambu, Inc.

    K Number Device Name
    K051529 AMBU NEUROLINE GROUND
    K042682 AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
    K042843 AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
    K041734 AMBU DISPOSABLE ECG ELECTRODE
    K040991 AMBU DISPOSABLE PRESSURE MANOMETER
    K041026 AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
    K032278 AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
    K032421 AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE
    K010583 AMBU GEL, HYDROGEL BURN DRESSING
    K993278 AMBU NEONATE SILICONE RESUSCITATOR
    Search all 33 clearances from Ambu, Inc. →