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

    ComPAS2

    K Number: K213872 · Decision Jul 15, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    227
    Applicant Total
    6
    Review Days
    214

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    Basic Information

    Device Name
    ComPAS2
    K Number
    K213872
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Morgan Scientific, Inc.
    Date Received
    December 13, 2021
    Decision Date
    July 15, 2022
    Product Code
    BZG
    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
    BZG Spirometer, Diagnostic

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    Other Clearances by Morgan Scientific, Inc.

    K Number Device Name
    K190568 ComPAS2 (Computerized Pulmonary Analysis System)
    K042595 SPIRO'AIR
    K022636 BODY BOX 5500
    K021200 COMPAS
    K013752 COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)