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

    SERVOMED BASIC BEDSIDE UNIT SMA 102-

    K Number: K832250 · Decision Jun 1, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    38
    Review Days
    326

    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
    SERVOMED BASIC BEDSIDE UNIT SMA 102-
    K Number
    K832250
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Litton Medical Electronics
    Date Received
    July 11, 1983
    Decision Date
    June 1, 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)

    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 Litton Medical Electronics

    K Number Device Name
    K840522 RECOMED BLOOD-FLOW METER H236-052-02
    K840899 SERVOMED ARRHYCOMP CENTRAL MONITOR SYS
    K840439 RECOMED CARDIAC OUTPUT METER 236067-
    K840523 SERVOMED PULSE AMPLIFIER MODULE-206-
    K840524 SERVOMED BASIC BEDSIDE UNIT SMV 110TP
    K840209 SERVOMED MEDIVISION SCOPE SMV-235
    K840832 SERVOMED OXCARDIORE SPIROGRAPH 324/111
    K840521 SERVOMED DIGITAL DISPLAY MODULE
    K832998 2-CHANNEL RECORDER
    K834600 RECOMB ECG PREAMPLIFIER/206 069 03
    Search all 38 clearances from Litton Medical Electronics →