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

    SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART

    K Number: K915833 · Decision Dec 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    89
    Applicant Total
    26
    Review Days
    344

    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
    SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART
    K Number
    K915833
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1880
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sensor Medics Corp.
    Date Received
    December 24, 1991
    Decision Date
    December 2, 1992
    Product Code
    BZC
    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
    BZC Calculator, Pulmonary Function Data

    Similar 510(k) Clearances

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

    STS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Vyntus/SentrySuite Product Line

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Vyntus BODY

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    COSMED K5 Wearable Metabolic Technology

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MiniBox +

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

    Other Clearances by Sensor Medics Corp.

    K Number Device Name
    K032516 HIOX80 AEROSOL ADAPTER
    K031745 INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
    K031883 LYRA NASAL MASK
    K030943 MODIFICATION TO HIOX
    K022192 PEGASUS NASAL CPAP SYSTEM
    K020665 HI-OX
    K012085 SOMNO STAR & SERIES SLEEP SYSTEM
    K012034 MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT
    K991972 INFANT FLOW SYSTEM
    K984254 INFANT FLOW NCPAP MASKS
    Search all 26 clearances from Sensor Medics Corp. →