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

    ECG PATIENT MONITOR

    K Number: K843376 · Decision Dec 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    6
    Review Days
    121

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    Basic Information

    Device Name
    ECG PATIENT MONITOR
    K Number
    K843376
    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
    August 28, 1984
    Decision Date
    December 27, 1984
    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.

    K Number Device Name
    K884645 PATIENT MONITOR RIGEL MODEL MULTICARE 429
    K875160 RIGEL MODEL MULTICARE 409
    K850407 NEONATAL MONITOR 309
    K850156 ECG PATIENT MONITOR 301
    K850155 ECG PATIENT MONITOR 302