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

    RECORDING UNIT, MODEL 1445

    K Number: K770829 · Decision May 18, 1977
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    13

    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
    RECORDING UNIT, MODEL 1445
    K Number
    K770829
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Scole Engineering Co.
    Date Received
    May 5, 1977
    Decision Date
    May 18, 1977
    Advisory Committee
    Unknown
    Review Advisory Committee
    CV
    Third Party
    N

    Other Clearances by Scole Engineering Co.

    K Number Device Name
    K923664 SCOLE 300 ECG RECORDER
    K822362 ALTA II ECG RECORDER
    K822363 ALTA III ECG RECORDER