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

    MASTERSCREEN PNEUMO & MASTERSCOPE

    K Number: K071753 · Decision Aug 14, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    62
    Applicant Total
    14
    Review Days
    47

    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
    MASTERSCREEN PNEUMO & MASTERSCOPE
    K Number
    K071753
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.1890
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Viasys Healthcare GmbH
    Date Received
    June 28, 2007
    Decision Date
    August 14, 2007
    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 Viasys Healthcare GmbH

    K Number Device Name
    K092324 SPIROPRO
    K091412 CLEAN PEAK FLOW METER
    K091505 COR12+
    K081823 MASTERSCREEN PAED - BABY BODY
    K080510 VIP PULMONARY FUNCTION SYSTEM
    K080734 FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
    K072061 MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY
    K072323 MASTERSCREEN & OXYCON CPX
    K062011 MODIFICATION TO FLOWSCREEN
    K070614 CORSCREEN
    Search all 14 clearances from Viasys Healthcare GmbH →