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

    PULMONARY FUNCTION TESTER

    K Number: K780584 · Decision May 16, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    62
    Applicant Total
    14
    Review Days
    35

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    Basic Information

    Device Name
    PULMONARY FUNCTION TESTER
    K Number
    K780584
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1890
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Warren E. Collins, Inc.
    Date Received
    April 11, 1978
    Decision Date
    May 16, 1978
    Product Code
    BTY
    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
    BTY Calculator, Predicted Values, Pulmonary Function

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    Other Clearances by Warren E. Collins, Inc.

    K Number Device Name
    K925459 GS-MODULAR (GOLD STANDARD - MODULAR)
    K912946 COLLINS DIGITAL PULMONARY MANOMETER
    K871151 THE SPIRA ELEKTRO 2
    K861227 COLLINS PNEUMOTACH PFT SYSTEM
    K852102 COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM
    K831780 METABOLIC EXERCISE TESTING SYSTEM
    K831777 COLLINS DS
    K831778 RS-RESIDUAL VOLUME SYSTEM
    K831779 COLLINS EAGLE II
    K803053 APEXLINE OF PULMONARY FUNCT. INSTRUM.
    Search all 14 clearances from Warren E. Collins, Inc. →