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

    SPIRO PRO

    K Number: K000648 · Decision Mar 29, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    62
    Applicant Total
    5
    Review Days
    30

    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
    SPIRO PRO
    K Number
    K000648
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.1890
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Erich Jaeger GmbH
    Date Received
    February 28, 2000
    Decision Date
    March 29, 2000
    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 Erich Jaeger GmbH

    K Number Device Name
    K023120 OXYCON MOBILE
    K023796 MS PAED-BABY BODY
    K021138 SLEEPSCREEN/APNOESCREEN CARDIO
    K001502 AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO