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

    CABINET FOR MULTIPLE FUNCTION BLOCKS

    K Number: K830795 · Decision May 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    9
    Review Days
    65

    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
    CABINET FOR MULTIPLE FUNCTION BLOCKS
    K Number
    K830795
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Electronics For Medicine, Inc.
    Date Received
    March 14, 1983
    Decision Date
    May 18, 1983
    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 Electronics For Medicine, Inc.

    K Number Device Name
    K830791 UNIVERSAL MEDDARS SYSTEM
    K792528 RESPIRATION/APNEA AMPLIFIER MODEL 3105
    K791006 SMART BILECTRODES
    K790198 MONITOR PLUG-IN MODEL M1106 ECG
    K790203 INTERVAL TIMER MODEL V4295
    K790185 MODEL V 4207 INTEGRATING PLUG-IN
    K780107 ANALYZER-PLUG-IN, CO2 MODEL M 3104
    K770366 ISOLATED ELECTROCARDIOGRAPH MODEL 1207