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

    ZIPPREP ELECTRODE

    K Number: K940802 · Decision Jun 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    328
    Applicant Total
    25
    Review Days
    120

    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
    ZIPPREP ELECTRODE
    K Number
    K940802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aspect Medical Systems, Inc.
    Date Received
    February 22, 1994
    Decision Date
    June 22, 1994
    Product Code
    DRX
    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
    DRX Electrode, Electrocardiograph

    Similar 510(k) Clearances

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

    Physiotrace

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOMODULE 3-M1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IP-SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X

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

    Other Clearances by Aspect Medical Systems, Inc.

    K Number Device Name
    K093183 BIS QUATRO SENSOR
    K091854 BIS CLICK SENSOR/CABLE
    K072286 BIS EEG VISTA MONITOR SYSTEM AND BISX
    K062613 BIS EEG MONITOR VIEW
    K070069 ZIPPREP ELECTRODE
    K062692 BIS BILATERAL SENSOR
    K052981 BIS EEG MONITOR, MODEL BISX4
    K052362 BIS EEG MONITOR, MODEL A-3000
    K050313 BIS SRS (SEMI-RESUABLE SENSOR)
    K041670 BIS PEDIATRIC SENSOR
    Search all 25 clearances from Aspect Medical Systems, Inc. →