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

    RIGEL MODEL MULTICARE 409

    K Number: K875160 · Decision Jun 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    6
    Review Days
    196

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    Basic Information

    Device Name
    RIGEL MODEL MULTICARE 409
    K Number
    K875160
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Rigel Medical Electronics, Inc.
    Date Received
    December 15, 1987
    Decision Date
    June 28, 1988
    Product Code
    DRT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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    Other Clearances by Rigel Medical Electronics, Inc.

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    K850155 ECG PATIENT MONITOR 302
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