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

    REUSABLE FINGER SENSOR 3444

    K Number: K974697 · Decision Mar 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    20
    Review Days
    85

    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
    REUSABLE FINGER SENSOR 3444
    K Number
    K974697
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bci Intl., Inc.
    Date Received
    December 16, 1997
    Decision Date
    March 11, 1998
    Product Code
    DQH
    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
    DQH Cardiograph, Apex (Vibrocardiograph)

    Other Clearances by Bci Intl., Inc.

    K Number Device Name
    K991086 CAPNOCHECK II, MODEL 8400
    K991410 3402 HANDHELD PULSE OXIMETER
    K984618 BCI MINI-TORR PLUS, MODEL 6004
    K983796 6004 NIBP MONITOR WITH TEMPERATURE
    K982279 VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200
    K981939 AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR
    K980714 BCI 3401 HANDHELD PULSE OXIMETER
    K970801 BCI MODEL 6004 NIBP MONITOR (6004)
    K970209 CAPNOCHECK PLUS
    K963496 OXI TEMP
    Search all 20 clearances from Bci Intl., Inc. →