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

    CALDYNE, INC. EXHALOMETER EX100, MODEL EX100

    K Number: K051279 · Decision Sep 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    60
    Applicant Total
    1
    Review Days
    113

    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
    CALDYNE, INC. EXHALOMETER EX100, MODEL EX100
    K Number
    K051279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1850
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Caldyne, Inc.
    Date Received
    May 17, 2005
    Decision Date
    September 7, 2005
    Product Code
    BZK
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BZK Spirometer, Monitoring (W/Wo Alarm)

    Similar 510(k) Clearances

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

    BEACON Caresystem Model 00002144

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ExSpiron 2Xi

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Gas Module 3

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ExSpiron 1Xi

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ExSpiron 1Xi

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EXSPIRON 1XI

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