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

    BREATH SHAKE

    K Number: K121587 · Decision Nov 22, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    57
    Applicant Total
    6
    Review Days
    540

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BREATH SHAKE
    K Number
    K121587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5665
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cheen Houng Ent. Co. , Ltd.
    Date Received
    May 31, 2012
    Decision Date
    November 22, 2013
    Product Code
    BYI
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BYI Percussor, Powered-Electric

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BYI), ordered by most recent decision date.

    AffloVest® Mobile Airway Clearance Therapy

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BreatheBand® (Model 1000)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LibAirty Airway Clearance System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Respiratory Muscle Trainer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    The Vest APX System (PVAPX1)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Electromed SmartVest Airway Clearance System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Cheen Houng Ent. Co. , Ltd.

    K Number Device Name
    K021390 PMX COMPACT RESUCITATOR
    K003927 Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
    K010191 Y2000 POCKET RESCUE
    K981415 0-20 CM H20 PEEP VALVE
    K970688 POCKET RESCUE