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

    SPIROS

    K Number: K915564 · Decision Jan 30, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    99
    Applicant Total
    20
    Review Days
    49

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    Basic Information

    Device Name
    SPIROS
    K Number
    K915564
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5925
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Life Support Products, Inc.
    Date Received
    December 12, 1991
    Decision Date
    January 30, 1992
    Product Code
    BTL
    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
    BTL Ventilator, Emergency, Powered (Resuscitator)

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    Other Clearances by Life Support Products, Inc.

    K Number Device Name
    K941870 LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100
    K941871 LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100
    K940934 LIFE VAC
    K936187 LSPI PRESSURE REGULATOR
    K932200 LSPI AUTOMATIC VENTILATOR
    K922819 INFANT DISPOSABLE BAG MASK RESUSCITATOR
    K922691 LSP (MODEL 554) BAG MASK RESUSCITATOR
    K932199 LSPI AUTOMATIC VENTILATOR, MODEL AV3000
    K921553 LSPI INFANT BAG MASK
    K921107 AUTOVAC
    Search all 20 clearances from Life Support Products, Inc. →