BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    CARDIORATER CR7

    K Number: K852910 · Decision Nov 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    8
    Review Days
    133

    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
    CARDIORATER CR7
    K Number
    K852910
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardiac Recorders, Ltd.
    Date Received
    July 9, 1985
    Decision Date
    November 19, 1985
    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)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DRT), ordered by most recent decision date.

    The Circadia C300 System (C300)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    The Circadia C300 System (C300)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sleepiz One+ (Model 2.5)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sleepiz One+ (2.5)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    The Circadia C200 System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Cardiac Recorders, Ltd.

    K Number Device Name
    K864704 CARDIAN III CR6A
    K861621 CARDIAN II CR45A
    K853673 CARDIORATER CR 51
    K852887 CR5 CARDIAC MONITOR
    K852905 CR 280/45, CR281/4 DEFIBRILLATOR
    K852799 2006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR)
    K852808 CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO)