BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    SENTRYSUITE PRODUCT LINE

    K Number: K122699 · Decision Nov 19, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    62
    Applicant Total
    12
    Review Days
    76

    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
    SENTRYSUITE PRODUCT LINE
    K Number
    K122699
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1890
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carefusion Germany 234 GmbH
    Date Received
    September 4, 2012
    Decision Date
    November 19, 2012
    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

    Similar 510(k) Clearances

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

    Ascent Cardiorespiratory Diagnostic Software

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SpiroSphere, SpiroSphereECG, CardioSphere

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Pulmonary Function Tester, Model: A9

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Virtus Metabolic Monitor

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Model 9100 PFT/DICO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU

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

    Other Clearances by Carefusion Germany 234 GmbH

    K Number Device Name
    K153654 Sentry WEB SmartInterp
    K150810 Vyntus / SentrySuite Product Line
    K142959 Vyntus Walk
    K141936 MICROBLAB, MICROLOOP
    K133925 VYNTUS/ SENTRYSUITE PRODUCT LINE
    K113813 SENTRYSUITE PRODUCT LINE
    K113096 MICRO I
    K111408 MICROGARD II
    K111053 SENTRYSUITE PRODUCT LINE
    K101873 MASTERSCREEN IOS
    Search all 12 clearances from Carefusion Germany 234 GmbH →