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

    PRONEB TURBO COMPRESSOR MODEL 38V0200

    K Number: K962072 · Decision Aug 21, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    8
    Review Days
    85

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    Basic Information

    Device Name
    PRONEB TURBO COMPRESSOR MODEL 38V0200
    K Number
    K962072
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pari Holding Co.
    Date Received
    May 28, 1996
    Decision Date
    August 21, 1996
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

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    Other Clearances by Pari Holding Co.

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    K963924 LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70
    K960675 WALKHALER PORTABLE COMPRESSOR MODEL 45F70
    K935540 PARI-MASTER MODIFICATION
    K944152 PARI BABY